Verify® 353101 (UDI 00643169968783)Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00643169968783), received between Feb 26, 2018 and Aug 11, 2021 — classified as 22 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (14 reports).

7 other recalls cover devices cleared under the same FDA submission (P080025, P970004); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2021Intermittent Continuity; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Data Problem; Intermittent Continuity; Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem; Data Problem

  INFORMATION WAS RECEIVED FROM A BASIC EVALUATION TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. THE TRIAL BEGAN (B)(6) 2021. IT WAS REPORTED THAT THE PATIENT'S THERAPY HAD TURNED OFF ON ITS OWN TWICE, COMPLETELY ZEROING OUT THEIR STIMULATION SETTINGS. THEY WERE ABLE TO TURN IT BACK ON AND PROGRAM THE SETTINGS AT A COMFORTABLE LEVEL OF 1.7 VOLTS. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). THE HCP REPORTED THAT THE CAUSE OF THERAPY TURNING OFF ON ITS OWN TWICE, COMPLETELY ZEROING OUT THE PATIENT'S STIMULATION SETTINGS WAS NOT DETERMINED. IT WAS UNKNOWN WHETHER OR NOT THIS ISSUE WAS RESOLVED. A LEAD REPLACEMENT OR RETRIAL WAS PLANNED. THE DATE OF SURGERY WAS PLANNED FOR (B)(6) 2021. THE CURRENT DEVICE WAS REMOVED ON (B)(6) 2021.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12310652 ↗
• InjuryJun 10, 2021Failure to Deliver Energy; Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT¿THE PATIENT THOUGHT THEY WERE UNDERGOING THE TRIAL FOR BOTH BLADDER AND BOWEL, BUT STATED "BASICALLY BLADDER". THEY REPORTED THAT STARTING FRIDAY, MARCH 5TH, THEY STOPPED FEELING STIMULATION AND STOPPED GETTING 50% REDUCTION IN SYMPTOMS (STATED THEY WERE PREVIOUSLY GETTING 50% REDUCTION IN SYMPTOMS). THEY MENTIONED THEY HAD AN APPOINTMENT WITH A PHYSICIAN ASSISTANT ON FRIDAY, AND THAT THEY WERE TOLD NOT TO TOUCH THERAPY SETTINGS UNTIL THEY WENT BACK TO THE HEALTHCARE PROVIDER. THEY WERE SCHEDULED TO COMPLETE THE TRIAL AND GET THE PERMANENT IMPLANT ON (B)(6) 2021. THEY DENIED ANY RECENT TRAUMA/FALLS. THEY WERE WALKED THROUGH CHECKING THE THERAPY STATUS ON THE CALL, AND CONFIRMED THERAPY WAS ON AT 2.4 VOLTS. THEY INQUIRED IF THEY SHOULD INCREASE STIMULATION. THEY WERE REDIRECTED TO THEIR HEALTHCARE PROVIDER TO DISCUSS INCREASING STIMULATION DURING THE TRIAL. EXTERNAL EQUIPMENT/THERAPY THEORY/USAGE WAS REVIEWED. THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE WERE UNKNOWN. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER

  Patient problems: Insufficient Information

  MAUDE report 11974323 ↗
• MalfunctionMay 24, 2021Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM AN ADVANCED EVALUATION TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE, URGENCY FREQUENCY. IT WAS REPORTED BY THE ADVANCED EVALUATION PATIENT THAT THEIR URGENCY LEVEL HAD IMPROVED BUT THEY WERE VOIDING THE SAME OR EVEN MORE TIMES A DAY NOW. ON 2021 (B)(6), THE PATIENT STATED THAT THEIR BACK WAS STILL SORE FROM THE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT AND HEALTHCARE PROFESSIONAL. THEY REPORTED THAT THEY HAD EXPERIENCED CONSTIPATION. ON 2021 (B)(6) THE HCP REPORTED THE ISSUE WAS RESOLVED. ON 2021-(B)(6) THE PATIENT REPORTED ALL OF HER BANDAGING HAS COME OFF AND IS CONCERNED ABOUT THE LEADS MIGRATING. SUPPORT LINK ADVISED PATIENT TO CONSULT HER DOCTOR WITH THIS INFORMATION.

  Patient problems: Constipation; Discomfort; Urinary Frequency / Polyuria

  MAUDE report 11871762 ↗
• InjuryMar 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT TOLERATED THE PNE PROCEDURE WELL WITHOUT COMPLICATIONS. AFTER AREA WAS DRESSED AND PATIENT BEGAN TO AMBULATE, THEY COMPLAINED OF RIGHT HIP AND LEG PAIN. IMPEDANCE WAS RECHECKED AND FOUND TO BE 98 SYSTEM REVIEW. THE MANUFACTURER REPRESENTATIVE (REP) RECOMMEND REMOVAL OF THE RIGHT LEAD. DRESSING WERE REMOVED AND RIGHT WIRE PULLED WITHOUT DIFFICULTY, AREA REDRESSED. THE PATIENT REPORTED THE PAIN WAS RESOLVED, DISCHARGED SETTINGS RECHECKED. THE PATIENT LEFT THE OFFICE PAIN FREE. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) AND MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT IN A CLINICAL STUDY (SDY). IT RE-STATED THAT ON (B)(6) 2021, THE PATIENT HAD RIGHT HIP AND LEG PAIN. AN INTERVENTION WAS TAKEN. THE LEFT LEAD IMPEDANCE WAS RECHECKED AND FOUND. THE REP REPORTED THE PATIENT HAD A HISTORY OF POTENTIAL NERVE ISSUES AFTER EPIDURAL IN THE PAST. AN ADVANCED PRACTICE REGISTERED NURSE (APRN) AND MANUFACTURER REPRESENTATIVE HAD RECOMM

  Patient problems: Pain

  MAUDE report 11408025 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED THE PATIENT¿S DRESSING KEPT COMING OFF MULTIPLE TIMES FOR DURATION OF STAGE 1. PATIENT HAD STAGE 1 ON (B)(6) 2020 BUT WAS NOT COMPLIANT WITH TRACKING SYMPTOMS ON THE DIARY, GETTING COVID TESTING PRIOR TO STAGE 2 MULTIPLE TIMES OR SHOWING UP FOR POST OP CARE IN HCP OFFICE FOR REPLACEMENT OF DRESSING. THE PATIENT WAS UNABLE TO GET IN FOR STAGE 2 UNTIL (B)(6) 2020 BECAUSE OF NOT GETTING COVID TESTED AND RETURNING REP AND OFFICE PHONE CALLS. MULTIPLE PHONE CALLS WERE MADE TO PATIENT AND PATIENT¿S DAUGHTER FROM THE REP AND PHYSICIAN OFFICE TO PROCEED TO STAGE 2 WITH SUCCESSFUL STAGE 1. THE REP CALLED THE PATIENT TWICE A DAY WITH MINIMAL RESPONSE OVER A 5 WEEK PERIOD. THE REP ALSO SET PATIENT UP FOR A FOLLOW UP APPOINTMENT BECAUSE THE DRESSING CAME OFF MULTIPLE TIMES BUT PATIENT DID NOT SHOW UP FOR THE APPOINTMENT. PATIENT HAD PAIN AND REDNESS AT POCKET SITE. ON (B)(6) 2020 PATIENT CAME IN FOR STAGE 2 BUT POCKET SITE WAS INFECTED WHEN THE SITE WAS OPENED. PATIENT WAS

  Patient problems: Erythema; Pain; Unspecified Infection

  MAUDE report 11008347 ↗
• MalfunctionNov 6, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WITH A STAGE 1 TRIAL, EXTERNAL NEUROSTIMULATOR (ENS) FOR FREQUENCY/PELVIC FLOOR THERAPY. IT WAS REPORTED THE PATIENT HAD STAGE 1 WEEK (B)(6) 2020 AND WAS IN FOR STAGE 2 (B)(6) AND THE REP NOTICED WHEN THEY OPENED THE POCKET THE HCP HAD TO SEARCH FOR THE PERC EXTENSION AS IT HAD MIGRATED. IT IS UNCLEAR WHEN IT MIGRATED, CAUSE WAS NOT DETERMINED. THE LEAD WAS NOT REPLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10798583 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE REGARDING AN ADVANCED EVALUATION TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGENCY FREQUENCY AND URGE INCONTINENCE. ON (B)(6) 2020, THE PATIENT REPORTED THAT THEY WERE PRETTY 'OUT OF IT' AFTER THEIR SURGERY. THEY ALSO SAID THAT THEY SLEPT MOST OF THE FOLLOWING DAY. ON (B)(6) 2020, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH AN ELEVATED HEART RATE 120-130S. THEY HAD A FULL SYSTEM REMOVAL IN THE OR THE FOLLOWING EVENING FOR A POSSIBLE INFECTION. THE HOSPITAL WAS SENDING THE LEAD AND EXTENSION FOR CULTURES TO TEST FOR THE INFECTION SOURCE. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO DEVICE ISSUES REPORTED, AND NO FURTHER PATIENT COMPLICATIONS REPORTED AT THIS TIME.

  Patient problems: Complaint, Ill-Defined; Tachycardia; Unspecified Infection

  MAUDE report 10788391 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT REPORTED SIGNIFICANT PAIN RIGHT AFTER SURGERY IN THEIR LEFT BUTTOCKS/SCIATIC NERVE, THAT GOES DOWN THEIR LEG. THIS OCCURRED BEFORE ANY THERAPY HAD BEEN TURNED ON. THE HEALTHCARE PROFESSIONAL (HCP) GAVE THEM SOME EXTRA NUMBING MEDICINE POST SURGERY AND THEN SOME PAIN MEDS TO GO HOME WITH. THE DEVICE HAD SINCE BEEN TURNED UP ON (B)(6) 2020 AND THE PATIENT SAID THAT THEIR PAIN WAS STILL THERE AS OF (B)(6) 2020, BUT NOT RELATED TO THE DEVICE NOW BEING TURNED ON. SURGICAL INTERVENTION WAS PLANNED TO OCCUR ON (B)(6) 2020. THERE WERE NO DEVICE ISSUES REPORTED, AND NO FURTHER PATIENT COMPLICATIONS REPORTED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT DID HAVE SOME SCIATIC NERVE ISSUE ON THEIR LEFT SIDE PRIOR TO IMPLANT. THEY HAD TRIED TURNING THE DEVICE OFF AND THEN BACK ON. ON (B)(6) 2020 THE PATIENT REPORTED THAT THE PAIN WAS NOW POSITIONAL AND THAT IT HAD IMPROVED, BUT HAD NOT GONE AWAY. IT WAS UNKNOWN AT THE T

  Patient problems: Pain

  MAUDE report 10750642 ↗
• MalfunctionOct 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE TRIAL PATIENT THE BASIC EVALUATION LEAD LOST INTEGRITY WHILE THE PHYSICIAN WAS INSERTING INTO FORAMEN NEEDLE. VERIFY EXTERNAL NEUROSTIMULATOR WOULD NOT POWER ON, TRIED 3 DIFFERENT SET OF BATTERIES, WAS DETERMINED THAT IT WAS A DEFECTIVE ENS. OPENED A NEW BE LEAD, AND THAT ONE WORKED AS EXPECTED. OPENED A NEW ENS, THAT ONE WORKED AS EXPECTED. THE ISSUE IS RESOLVED AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10691359 ↗
• MalfunctionOct 14, 2020Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN ADVANCED EVALUATION TRIAL DEVICE FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY POST-OPERATIVELY. IT WAS REPORTED THE PATIENT HAD A SHOCKING SENSATION IN THE LOWER BACK ON THE SAME SIDE AS THE INCISION. PATIENT WAS LAYING DOWN AND MAY HAVE ROLLED, PUSHING LEAD AND STIM UP AGAINST THE NERVES; THEY MASSAGED THE BACK AND PROBLEM WENT AWAY. AFTER MASSAGING THE SITE IT DID NOT HAPPEN AGAIN AND THE ISSUE WAS RESOLVED.

  Patient problems: Electric Shock

  MAUDE report 10678021 ↗
• InjuryOct 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HCP REPORTED THAT PATIENT WAS GIVEN ANTIBIOTIC. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED AT THIS TIME.

  Patient problems: Fluid Discharge; Post Operative Wound Infection

  MAUDE report 10663062 ↗
• InjuryOct 9, 2020High impedance; Battery Problem; High impedance; Battery Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) VIA TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE AND URGENCY FREQUENCY; THE TRIAL BEGAN ON (B)(6) 2020. IT WAS REPORTED THAT THE REP IS CURRENTLY WITH THE PATIENT POST-OP DURING STAGE 1 TRIAL IMPLANT. THE REP REPORTED OUT OF RANGE (OOR) ON ALL COMBINATIONS BUT REPORTED 2 AND 3 ELECTRODES GREATER THAN >4,000 OHMS. THE CALLER PROGRAMMED 0 AND 1 ELECTRODES WITH SIMILAR RESULTS BUT DID NOT ASK THE IMPEDANCE VALUE. THE CALLER HAD LIMITED TIME TO REPORT TO THE SURGEON ON TAKING THE PATIENT BACK TO RESEAT THE LEAD/EXTENSION CONNECTION. THE CALLER ASKED ABOUT REPLACING THE ENS BUT DID REPORT IT IS UNLIKELY THE CAUSE OF THE IMPEDANCE ISSUES, BUT COULD TRY IT. THE FOLLOWING DAY, THE PATIENT STATED THEY HAD A BOWEL ACCIDENT IN BED LAST NIGHT AND DIDN'T KNOW IT. THE PATIENT WAS REALLY OUT OF IT YESTERDAY AND SLEPT FROM 8PM TO THIS MORNING. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) AND A PATIENT ON (B)(6) 2020. IN RESPONSE TO THE INQUIRY FOR IF THE CAUSE OF THE OUT OF RANGE COMBINATION OF 2 & 3 ELECTRODES >4000 OHMS HAD

  Patient problems: Complaint, Ill-Defined; Incontinence

  MAUDE report 10659835 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT THAT WAS UNDERGOING AN ADVANCED EVALUATION WITH AN EXTERNAL NEUROSTIMULATOR. THE PATIENT'S MEDICAL HISTORY INCLUDED OVERACTIVE BLADDER, FECAL INCONTINENCE, AND RADIATION THERAPY. IT WAS REPORTED THAT THE PATIENT CALLED THE REP TO TELL THEM THAT THEY WOKE UP AT 1 A.M. HAVING A LOT OF STIMULATION FROM THE DEVICE IN THEIR PELVIS AND ALL THE WAY INTO THEIR HEAD, CAUSING A BAD HEADACHE. THEY THEN TOLD THE REP THAT IT WAS MAKING THEM HAVE SUICIDAL THOUGHTS. THEY CHECKED THE STIMULATION LEVEL, WHICH WAS SET AT 0.1 MA. THE REP INSTRUCTED THE PATIENT TO TURN IT OFF. THE PATIENT SAID THE HEADACHE DID NOT RESOLVE, BUT IT WAS POSSIBLY GETTING BETTER. THE REP TEXTED THE PATIENTS PHYSICIAN TO NOTIFY THEM IMMEDIATELY OF THE SUICIDAL THOUGHTS. THE REP ALSO CONTACTED THE POLICE IN THE PATIENT'S CITY TO REQUEST A WELLNESS CHECK AND WERE TOLD THAT THE POLICE WOULD BE RIGHT OVER. THAT EVENING THE REP RECEIVED A MESSAGE FROM THE PHYSICIAN THAT THE PATIENT HAD BEEN TAKEN TO THE HOSPITAL FOR EVALUATION AND WAS DOING OKAY. LATER THAT EVENING, THE REP RECEIVED A PHONE CALL FROM THE PATIENT REQUESTING THAT THEIR D

  Patient problems: Cognitive Changes; Headache; Therapeutic Effects, Unexpected

  MAUDE report 10645058 ↗
• InjuryOct 2, 2020Break; Failure to Deliver Energy; Break; Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS) FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED THE PATIENT HAD A STAGE 1 SYSTEM PLACED (B)(6) 2020. THE PATIENT WASN'T FEELING STIM AND DIDN'T THINK THAT THE SYSTEM WAS WORKING BECAUSE THEY WERE GOING TO THE BATHROOM FREQUENTLY LAST NIGHT. TODAY THE REP MET THE PATIENT IN THE HCP OFFICE, AND THEY NOTICED THAT THE PERC EXTENSION CABLE WAS CUT. THEY DO NOT KNOW HOW THE DEVICE WAS DAMAGED. THE CALLER STATED THAT THEY ARE GOING TO PLACE A NEW PERC EXTENSION NEXT WEEK TO CONTINUE THE TRIAL. ON 2020-SEP-25 ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE AND HCP: THE PATIENT'S INDICATION FOR USE IS OVERACTIVE BLADDER. THE CAUSE OF THE BREAK IN THE CABLE IN NOT KNOWN, BUT IT LOOKED LIKE THE CABLE HAD BEEN CUT PER THE PHYSICIAN. THE PATIENT HAD A REVISED STAGE 1 ON (B)(6) 2020 TO HAVE A NEW PERCUTANEOUS EXTENSION CABLE PUT IN TO COMPLETE THEIR STAGE 1 TRIAL.

  Patient problems: Therapeutic Effects, Unexpected; Urinary Frequency / Polyuria

  MAUDE report 10621691 ↗
• InjurySep 8, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT AN ADVANCED EVALUATION TRIAL DEVICE FOR GASTROINTESTINAL /PELVIC FLOOR THERAPY; TRIAL BEGAN (B)(6) 2019. IT WAS REPORTED THE PATIENT STATED LAST NIGHT THAT SHE FELT SHE HAD PULLED ON THE PERCUTANEOUS EXTENSION SET AND DISLODGED THE LEAD AFTER RESUMING NORMAL ACTIVITIES AND HAD PAIN IN LEG AND TAILBONE. FLUOROSCOPY ESTABLISHED THAT THE LEAD HAD IN FACT BEEN MOVED OUT WITH ONLY ELECTRODE 0 AT ANTERIOR EDGE OF SACRUM. THE LEAD WAS EXPLANTED, NEW LEAD IMPLANTED AND STAGE 2 COMPLETED TO RESOLVE THE ISSUE. THE PATIENT'S PAIN RESOLVED ONCE THE LEAD WAS REMOVED AND REPLACED INTO A GOOD POSITION.

  Patient problems: Pain

  MAUDE report 10505081 ↗
• InjurySep 2, 2020Energy Output Problem; Insufficient Device Problem Information; Energy Output Problem; Insufficient Device Problem Information

  THE MANUFACTURE REPRESENTATIVE REPORTED THAT DURING THE BASIC EVALUATION THE ELECTRODE DIDN'T WORK. THE SPHINCTER DIDN'T CONTRACT DURING MEASUREMENT. AFTER SEVERAL TRIALS WE DECIDED TO IMPLANT A NEW BASIC EVALUATION LEAD. AFTERWARDS THE SPHINCTER CONTRACTED AS IT SHOULD. IT WAS NOTED THAT THERE WAS NO IMPROVEMENT OF SYMPTOMS, BECAUSE OF A LACK OF STIMULATION AT SACRAL NERVES. IT WAS NOTED THAT A NEW BASIC EVALUATION LEAD WAS IMPLANTED ON (B)(6) 2020.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10483268 ↗
• MalfunctionAug 31, 2020Break; Intermittent Continuity; Failure to Deliver Energy; Failure to Interrogate; Migration or Expulsion of Device; Battery Problem; Communication or Transmission Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information; Break; Intermittent Continuity; Failure to Deliver Energy; Failure to Interrogate; Migration or Expulsion of Device; Battery Problem; Communication or Transmission Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT WITH A TRIAL EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. THE PATIENT STATED THAT THE PROGRAMMER WASN'T WORKING AS SHE DIDN'T FEEL THE STIMULATION ANY LONGER. THE PATIENT WAS ADVISED THAT IT IS POSSIBLE TO GET USED TO THE STIMULATION AND NOT FEEL IT OR NOTICE IT AND STILL GET EFFECTIVE THERAPY. THE PATIENT DID SAY THAT SHE TRIED TO INCREASE THE STIMULATION SETTING BUT SHE WOULD GET A MESSAGE THAT SAID LIMIT REACHED. THE PATIENT STATED SHE DECREASED THE STIMULATION FROM 0.8 TO 0.6 AND STILL GOT THE LIMIT REACHED MESSAGE. THE PATIENT ALSO STATED SHE WOULD GET A COMMUNICATION ERROR. WHILE ON THE LINE WITH SUPPORT LINK THE PATIENT DECREASED THE STIMULATION TO 0 IN ORDER TO INCREASE THE STIMULATION. THE PATIENT WAS NOT ABLE TO GET PAST THE MESSAGE WINDOW ABOUT THE THERAPY BEING TURNED OFF. THE PATIENT WAS INSTRUCTED TO RESTART THE PROGRAMMER. UPON RESTARTING THE PROGRAMMER AND GETTING BACK INTO THE MY THERAPY APP THE PROGRAMMER SAID IT WAS COMMUNICATING BUT IT WASN'T ABLE TO CONNECT WITH THE ENS DEVICE; THE PROGRAMMER SAID THAT A LEAD OR SOMETHING WAS LOOSE OR DISCONNECTED. PATIENT STATED THAT HER DEV ICE IS STILL

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 10475213 ↗
• InjuryJan 31, 2020High impedance; Connection Problem; Impedance Problem; Therapeutic or Diagnostic Output Failure; High impedance; Connection Problem; Impedance Problem; Therapeutic or Diagnostic Output Failure

  ON 2020-JAN-21 (B)(4) (REP): INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS USING AN EXTERNAL WITH A NEUROSTIMULATOR (INS) IT WAS REPORTED THAT THE PATIENT IS INTRODUCED TO OP FOR STAGE 1 AND KEPT GETTING AN IMPEDANCE ISSUE. THE CALLER HAD REPLACED THE ENS, CONNECTOR CABLE AND WOULD SEE MAX LIMIT REACHED. THE CALLER HAD POWER CYCLED HER SAMSUNG DEVICE WITH NO SUCCESS. THE CALLER WANTED TO KNOW IF THERE WAS ANYTHING ELSE TO TRY BEFORE THEY OPEN THE PATIENT UP AND REPLACE THE CONNECTOR. THE TECHNICAL SERVICE REVIEWED THAT IF ALL EXTERNAL COMPONENTS HAVE BEEN REPLACED THEN THE NEXT WOULD BE TO LOOK AT A MORE INVASIVE TROUBLESHOOTING STEP. THE CALLER DID NOT HAVE TIME TO PROVIDE INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PHYSICIAN CHANGED OUT THE LEAD EXTENSION AND IT WORKED. THE LEAD EXTENSION DID NOT SEEM TO LET THE LEAD FULLY SEAT ALL THE WAY IN, THUS THE IMPEDANCES WERE OFF AND MAX LIMIT WAS REGISTERING EVEN THOUGH THE DEVICE WAS ONLY AT 0.2. THE PHYSICIAN UNSCREWED THE LEAD EXTENSION SCREW THINKING THAT WAS THE HOLDUP BUT THAT DID NOT RESOLVE THE PROBLEM. A NEW EXTENSION WAS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9655582 ↗
• MalfunctionDec 10, 2019Break; Migration or Expulsion of Device; Energy Output Problem; Stretched; Environmental Compatibility Problem; Break; Migration or Expulsion of Device; Energy Output Problem; Stretched; Environmental Compatibility Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE STAGE 1 TRIAL WAS WORKING FINE BUT THE DAY OF THE CALL THE PATIENT WAS UNABLE TO GO ABOVE 0.4 MA. IT WAS REVIEWED THAT THERE WAS A POSSIBLE CONNECTION ISSUE, BUT THE REP WAS NOT WITH THE PATIENT FOR TROUBLESHOOTING. THE REP NOTED THEY WOULD MEET WITH THE PATIENT THE DAY OF THE CALL. IT WAS NOTED THAT THE TRIAL BEGAN ON (B)(6) 2019 ON A SECOND CALL, THE REP REPORTED THE PATIENT HAD PULLED THE WHOLE GRAY WIRE, THE CABLE DISCONNECTED, SNAPPED, AND SEVERED. THE PATIENT WAS DOING FINE, AND THEY DID HAVE GREAT SUCCESS WITH THE TRIAL, SO THEY WERE GOING NEXT WEEK FOR THE STAGE 2 IMPLANT. ON (B)(6) 2019 THE REP REPORTED THAT THE LEAD WAS DAMAGED AND HAD MIGRATED FROM THE PATIENT DURING THEIR TRIAL. THE REP INDICATED THAT STRETCHING HAD OCCURRED, AND THE PATIENT MUST HAVE GOTTEN IT CAUGHT ON SOMETHING. THE REP REPORTED THE DAMAGED LEAD WAS REMOVED AND A NEW LEAD WAS INSERTED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9445607 ↗
• MalfunctionOct 28, 2019Break; Communication or Transmission Problem; Connection Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information; Break; Communication or Transmission Problem; Connection Problem; Therapeutic or Diagnostic Output Failure; Insufficient Device Problem Information

  2019-SEP-30 (B)(4) (CON, REP): INFORMATION WAS RECEIVED FROM A CONSUMER AND A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN ADVANCED EVALUATION TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED BY AN ADVANCED EVALUATION PATIENT ON (B)(6) 2019 THAT THEY REACHED MAXIMUM STIMULATION AT 1.2 ON PROGRAM 2. WHILE ATTEMPTING TO CHANGE THEIR PROGRAM, THE PATIENT REACHED MAXIMUM STIMULATION AT 0.1 ON PROGRAMS 3, 4 AND 5. WHILE ATTEMPTING TO CHANGE THE PATIENT TO PROGRAM 6, THEY RECEIVED A SERIAL COMMUNICATION ERROR (B)(4). THE PATIENT WAS REFERRED TO THEIR CLINICIAN¿S OFFICE. ON (B)(6)2019 THE PATIENT MENTIONED THEY REACHED MAXIMUM STIMULATION AND THEY WERE RECEIVING A COMMUNICATION ERROR WHEN TRYING TO SWITCH SIDES. THE PATIENT WAS THEN TRANSFERRED TO PATIENT AND TECHNICAL SERVICES (PATS). THE PATIENT, WHO HAD THEIR EVALUATION BEGIN/ENS IMPLANTED ON WEDNESDAY (B)(6) 2019, REPORTED TO PATS THAT THEY DID NOT THINK THE DEVICE WAS DOING ANYTHING ON WEDNESDAY AND THURSDAY. THE PATIENT STATED THEY INCREASED IT FROM 8 TO 10 AND THEN CALLED THE OFFICE AND THEY LEFT IT AT 0.2. THE PATIENT STATED THEY DID NOT HAVE TO GET UP THAT NIGHT TO GO TO THE BATHROOM AND THE FOLLOWING DAY I

  Patient problems: Pain; Therapeutic Response, Decreased

  MAUDE report 9246610 ↗
• InjuryJul 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE PATIENT HAD REDNESS, THE HEALTHCARE PROVIDER SUSPECTED INFECTION, AT THE LEAD SITE. IT WAS NOTED THAT THE SYMPTOMS WERE SUDDEN. THE REP LATER REPORTED THAT THE PATIENT ALSO HAD WARMTH OF THE POCKET SITE AND A FEVER AT SOME POINT DURING THE TRIAL. THE PRODUCT WAS REMOVED TO TRY TO RESOLVE THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) INDICATING THAT THE REP HAD NOT HEARD IF THE INFECTION AND OTHER SYMPTOMS WERE RESOLVED AFTER REMOVING THE LEAD. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Burning Sensation; Erythema; Fever; Unspecified Infection

  MAUDE report 8747903 ↗
• InjuryMay 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A STAGE 1 TRIAL PATIENT. IT WAS REPORTED THAT AN INFECTION DEVELOPED APPROXIMATELY 1 WEEK FOLLOWING THE START OF STAGE 1. IT WAS NOTED THAT STAGE 1 WAS PERFORMED VIA STERILE SURGERY. THE PATIENT CALLED THE OFFICE ON MONDAY, 2019-APR-22 STATING THAT THEIR INCISION HAD BECOME STIFF ON (B)(6) 2019 AND THE PATIENT APPLIED A HEATING PAD, WHICH HAD MADE IT FEEL BETTER. ON MONDAY MORNING, THE PATIENT¿S INCISION HAD BEEN RED, VERY PAINFUL AND HAD STARTED THE DAY BEFORE. THE PATIENT STATED THEIR INCISION HAD BEEN OOZING RED/YELLOWISH FLUID AFTER THE PROCEDURE AND THEY HAD CHANGED THEIR DRESSING AT HOME. IT WAS NOTED THE PATIENT DENIED FEVER. THE PATIENT WAS THEN BROUGHT INTO THE OFFICE ON (B)(6) 2019 AND IT WAS RED, SWOLLEN AROUND THE INCISION AND YELLOW CRUSTY INSIDE THE EXIT HOLE OF THE EXTENSION. IT WAS DECIDED THAT THE PATIENT HAD BECOME INFECTED/DEVELOPED AN INFECTION AT THE CONNECTION SITE AND THE EXIT SITE OF THE PERCUTANEOUS EXTENSIONS, AND THEY WERE SCHEDULED FOR SURGERY ON THE SAME DAY FOR REMOVAL OF THE DEVICE. IT WAS NOTED THE PATIENT HAD REPORTED THAT THEIR INCISION HAD BEE

  Patient problems: Complaint, Ill-Defined; Erythema; Fluid Discharge; Insufficient Information; Pain; Post Operative Wound Infection; Swelling; Unspecified Infection

  MAUDE report 8614277 ↗
• MalfunctionApr 24, 2019Migration or Expulsion of Device; Connection Problem; Therapeutic or Diagnostic Output Failure; Migration or Expulsion of Device; Connection Problem; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A TRIAL PATIENT WHO WAS IMPLANTED ON (B)(6) 2019 FOR A VERIFY ENHANCED BASIC EVALUATION (BE) FOR URGE INCONTINENCE. IT WAS REPORTED THAT THE TRIAL PATIENT TRIED TO INCREASE THE STIMULATION BUT GOT A ¿MAXIMUM SETTING¿ MESSAGE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THIS ISSUE AS A ¿CONNECTION ERROR¿ MESSAGE WAS THEN SEEN. FURTHER TROUBLESHOOTING DID NOT RESOLVE THE ISSUES. FOLLOW UP INFORMATION RECEIVED FROM THE TRIAL PATIENT ON (B)(6) 2019 REPORTED THAT THEIR DEVICE WAS STILL NOT WORKING AND WAS TURNED OFF. THE PATIENT CONTACTED THEIR CLINICIAN AND THEY WERE NOT AVAILABLE UNTIL MONDAY. FOLLOW UP INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE ON (B)(6) 2019 REPORTED THAT THE CAUSE OF THE MAXIMUM SETTINGS/CONNECTION ERROR WAS THAT THE WIRES HAD PULLED OUT FROM THEIR INITIAL PLACEMENT. AS A ACTION TAKEN, THE HCP STAFF WERE COMPLETELY REMOVED. THE ISSUE WAS REPORTED AS RESOLVED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8546153 ↗
• MalfunctionApr 11, 2019Failure to Deliver Energy; Migration or Expulsion of Device; Therapeutic or Diagnostic Output Failure; Failure to Deliver Energy; Migration or Expulsion of Device; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A TRIAL PATIENT WHO WAS IMPLANTED ON (B)(6) 2019 FOR A VERIFY ENHANCED BASIC EVALUATION (BE) FOR FECAL INCONTINENCE. IT WAS REPORTED THAT THE TRIAL PATIENT WAS HURTING THROUGH CHURCH (¿JUST PAIN¿). THEY ALSO REPORTED THAT THEY HAD DIARRHEA AND A LOT OF GAS. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2019 FROM THE TRIAL PATIENT REPORTED THAT THEY WERE NOT SEEING 50% OR GREATER REDUCTION IN SYMPTOMS SO IT WAS ADVISED TO SWITCH TO THE RIGHT SIDE. THE PATIENT STATED THAT THE RIGHT SIDE ¿DOESN'T WORK¿. THEY DID NOT FEEL ANY STIMULATION AND THEY ¿MAXED OUT¿ ON THEIR SETTINGS. THE PATIENT STATED THAT THEY WERE TO STAY ON THE LEFT SIDE THROUGHOUT THE EVALUATION AND NO THERAPY CHANGES WERE MADE. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED TO THE ISSUE. IT WAS ADVISED THAT THE PATIENT CONTACT THEIR CLINICIAN FOR THE ISSUE. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF REPORT. IT WAS UNKNOWN IF ANY SURGICAL INTERVENTION HAD OCCURRED OR IF ANY WERE PLANNED. THE PATIENT STATUS WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) ON (B)(6)

  Patient problems: Diarrhea; Flatus; Pain

  MAUDE report 8505689 ↗
• InjuryFeb 7, 2019Energy Output Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure; Energy Output Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem; Therapeutic or Diagnostic Output Failure

  INFORMATION WAS RECEIVED FROM A CONSUMER AND A MANUFACTURER¿S REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR NON-OBSTRUCTIVE URINARY RETENTION. IT WAS REPORTED THAT THE PATIENT WAS NOT FEELING VERY GOOD. ON A SECOND CALL, THE PATIENT REPORTED THEY WERE RECEIVING THE MAXIMUM SETTINGS ERROR MESSAGE ON THEIR PROGRAMMER. ON THE CALL, THEY ATTEMPTED TO LOWER AND RAISE STIMULATION AND TRY A DIFFERENT PROGRAM, BUT THEY WERE STILL RECEIVING THE SAME ERROR. THE PATIENT WAS ADVISED TO CONTACT THEIR HEALTHCARE PROVIDER AND THEIR REP WAS MADE AWARE. ON A THIRD CALL THE REP REPORTED THEY WERE UNABLE TO INCREASE THE AMPLITUDE ABOVE 1.0MA. THE REP STATED 0, 1, AND 2 WERE GREEN, SO THEY DIDN¿T UNDERSTAND WHY THEY COULDN¿T GET HIGHER VALUES FOR AMPLITUDE THE DAY OF THE CALL. THE REP ALSO REPORTED THAT THEY RAN AN IMPEDANCE TEST AND IT SHOWED AN ISSUE WITH CONTACT 3. TROUBLESHOOTING COULD NOT BE CONTINUED AS THE REP NEEDED TO GO SEE THE PATIENT. IT WAS REVIEWED THAT IF IMPEDANCES WERE HIGH IT WOULD LIMIT THE AMP VALUE THAT COULD BE ACHIEVED. THE REP STATED THAT PROGRAM 7 WAS WORKING FOR THE PATIENT THE DAY OF THE CALL. IT WAS REVIEWED TO CHECK CONNECTION

  Patient problems: Malaise

  MAUDE report 8315591 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P080025, P970004. One submission often covers many models, so check the product and lot details in each record.

• Z-1704-2025 · Apr 3, 2025 · Open, Classified
  Enhanced Verify Evaluation Handset (CFN HH90130FA)
• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-2365-2023 · Jul 6, 2023 · Open, Classified
  Medtronic InterStim Ground Pad REF 041826
• Z-0998-2022 · Feb 28, 2022 · Terminated
  MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA,
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-0037-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim II INS Model 3058 with N'Vision InterStim-B Software supplied on the Model 8870 Version MMB_01/NNB_01 N'Vision with a Clinic an Programmer Model 8840. Implanta
• Z-0040-2008 · Jun 25, 2007 · Terminated
  Medtronic InterStim INS (Model 3023) with N'Vision Inter Stim-B software supplied on the Model 8870 Version MMB_01/NNB_01 with N'Vision Clinician Programmer Model 8840 or InterStim