VERIFY™ 3531 (UDI 00643169725072)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169725072), received between Jun 29, 2017 and Dec 9, 2024 — classified as 12 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE STEPS FOR RESOLUTION WAS UNKNOWN. THE LEAD WAS STILL IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20881170 ↗
• InjuryJul 22, 2019Failure to Deliver Energy; Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT IMPLANTED FOR A TRIAL EVALUATION. IT WAS REPORTED THAT THE TRIAL PATIENT HAD NOT SEEN ANY RESULTS FROM THE TRIAL EVALUATION AS OF YET. THE REPORTER STATED THAT THE PATIENT WOULD VOID AROUND 300 AND THE WOULD BE A RESIDUAL OF 700-800. THE PATIENT WOULD VOID 100% BUT STILL HAD RESIDUAL WHEN THEY HAD TO CATHETERIZE. IT WAS MENTIONED THAT THE PATIENT WAS UNABLE TO FEEL AN URGE TO USE THE RESTROOM. THE REPORTER HAD CONTACTED THE MANUFACTURER¿S REPRESENTATIVE ABOUT THE ISSUE AND WAS TOLD TO CALL THE MANUFACTURER FOR SUGGESTIONS. OPTIONS OF THE POSSIBILITY OF INCREASING THE STIMULATION OR CHANGING SIDES WERE REVIEWED WITH THE REPORTER. THE REPORTER NOTED THAT THE TRIAL PATIENT ONLY HAD ACCESS TO THEIR CURRENT SETTINGS AND WAS UNABLE TO CHANGE SIDES OR ADJUST SETTINGS. THEY WERE CURRENTLY SET AT 4.2 VOLTS, PRESUMABLY ON THE LEFT SIDE, AND DID NOT FEEL THE STIMULATION. THE REPORTER ALSO NOTED THAT THE PATIENT HAD A CLEAR SUBSTANCE COMING FROM THE INCISION SITE WHICH STARTED ON THE IMPLANT DATE OF THE TRIAL ((B)(6) 2019). THEY WANTED TO KNOW WHAT THIS WAS BUT WAS REDIRECTED TO THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) FOR THE I

  Patient problems: Micturition Urgency; Therapeutic Effects, Unexpected; Urinary Retention

  MAUDE report 8811079 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, (B)(4) (CON): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN ADVANCED EVALUATION TRIAL DEVICE FOR GASTROINTESTINAL/PELVIC FLOOR THERAPY. IT WAS REPORTED THAT THE PATIENT HAD SIGNS OF INFECTION AND PAIN AT LEAD INSERTION, POCKET, AND EXTERNAL WIRE EXIT SITES. INTRAOPERATIVELY THERE WAS PUS AT ALL 3 SITES. THE PHYSICIAN REMOVED ALL IMPLANTED DEVICES AND COPIOUSLY IRRIGATED THE SITE. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

  Patient problems: Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 7973933 ↗
• InjurySep 7, 2018Failure to Deliver Energy; Installation-Related Problem; Failure to Deliver Energy; Installation-Related Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR. IT WAS REPORTED THAT THE PATIENT STOPPED FEELING STIMULATION. THE PATIENT MENTIONED THAT HE HAD CHANGED BETWEEN A COUPLE OF PROGRAMS. TROUBLESHOOTING ATTEMPTS WERE MADE AND STIMULATION WAS ON. IT WAS NOTED THAT THE PATIENT WAS SET TO PROGRAM 7 AT 8.0. ON (B)(6), THE PATIENT REPORTED THAT THE PATIENT SAW THE MESSAGE THAT THE DEVICE WAS NOT SET UP PROPERLY FOR THE PATIENT'S USE, "CONTACT YOUR CLINICIAN. TURN OFF THERAPY/END SESSION". THE PATIENT CONFIRMED THAT THE TRIAL WAS WORKING WELL AND IT WAS MAKING HIM PEE MORE WITH A GOOD FLOW BUT NOW HE WAS PEEING LESS AND HAD THE URGE TO GO AGAIN BUT NOTHING COMES OUT. THE PATIENT WAS REDIRECTED TO HIS HEALTH CARE PROFESSIONAL. THERE WERE NO FURTHER SYMPTOMS OR COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Micturition Urgency; Therapeutic Effects, Unexpected; Urinary Retention

  MAUDE report 7855789 ↗
• MalfunctionAug 30, 2018Failure to Deliver Energy; Migration or Expulsion of Device; Failure to Deliver Energy; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS) FOR TRIAL STIMULATION WHO REPORTED THAT THE PATIENT INCREASED STIMULATION UP TO THE MAXIMUM SETTING, BUT WAS NO LONGER FEELING STIMULATION. THE PATIENT INDICATED THAT THEY WERE INSTRUCTED TO USE BOTH SIDES FOR 2 DAYS TO EVALUATE AND THE PATIENT HAD ALREADY PREVIOUSLY BEEN ON THE RIGHT SIDE, BUT CHANGED TO THE LEFT SIDE ON (B)(6). AFTER COMPLETING 2 DAYS OF EVALUATION THE PATIENT DECIDED THAT THEY WANTED TO TRY THE RIGHT SIDE AGAIN TO SEE IF THEY WOULD SEE BETTER PROGRESS. PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT. THERE WERE NO FURTHER COMPLICATION REPORTED OR ANTICIPATED. FOLLOW-UP WITH THE PATIENT'S HEALTHCARE PROVIDER (HCP) DETERMINED THAT ACTIONS TAKEN ON (B)(6) 2018 WERE TO MANAGE BEHAVIORALLY AND THAT THE CAUSE OF THE LOSS OF STIMULATION WAS "DISLODGED." PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT. THERE WERE NO FURTHER COMPLICATION REPORTED OR ANTICIPATED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7833881 ↗
• MalfunctionApr 26, 2018Migration or Expulsion of Device; Device Displays Incorrect Message; Migration or Expulsion of Device; Device Displays Incorrect Message

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH A BASIC EVALUATION TRIAL DEVICE TO TREAT URGE INCONTINENCE AND URGENCY FREQUENCY; THE TRIAL BEGAN (B)(6) 2018. ON (B)(6) 2018 IT WAS REPORTED THE TRIAL PATIENT WAS UNCOMFORTABLE ON HER RIGHT SIDE. ALSO, HER DEVICE WAS DISPLAYING "SETTINGS UNAVAILABLE, CALL YOUR CLINICIAN". THE MANUFACTURER'S REPRESENTATIVE WAS FLAGGED TO CALL THE PATIENT TO HELP HER SWITCH SIDES BACK. ON (B)(6) 2018 THE MANUFACTURER'S REPRESENTATIVE REPORTED THE HEALTHCARE PROFESSIONAL INFORMED THEM THAT THE CAUSE OF THE "SETTINGS UNAVAILABLE, CALL YOUR CLINICIAN" WAS DUE TO THE WIRES HAD MOVED SLIGHTLY. THE "SETTINGS NOT AVAILABLE" SEEN ON THE EXTERNAL DEVICE WAS NOT RESOLVED AS THE TRIAL LEADS WERE REMOVED. THE PATIENT'S DISCOMFORT RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

  Patient problems: Discomfort

  MAUDE report 7466446 ↗
• InjuryApr 26, 2018Device Displays Incorrect Message; Battery Problem; Device Operates Differently Than Expected; Device Displays Incorrect Message; Battery Problem; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR EXTERNAL NEUROSTIMULATOR (ENS). PATIENT REPORTED THAT HE WAS ON THE TRIAL FOR HIS BLADDER THAT HE STARTED 3 WEEKS AGO, AND HIS DEVICE WAS NOT WORKING, BECAUSE HE WAS GETTING A COMMUNICATION ERROR. PATIENT WAS ASKED WHAT PATIENT WAS SEEING ON THE SCREEN THAT INDICATED COMMUNICATION ERROR. PATIENT REPORTED COMMUNICATION ERROR, SERIAL NUMBER, EXTERNAL DEVICE BATTERY AND IT STATED THAT EXTERNAL DEVICE BATTERY HAD DEPLETED, AND THERAPY HAD STOPPED. PATIENT WAS ASKED IF PATIENT SAW A SCREEN NUMBER TO VERIFY THE SCREEN THE PATIENT WAS SEEING, BUT THE PATIENT REPORTED IT DID NOT GIVE A SCREEN NUMBER. IT WAS REVIEWED WITH THE PATIENT THAT THE PATIENT¿S ENS BATTERY MIGHT POTENTIALLY NEED TO BE CHANGED AND ADVISED THE PATIENT TO FOLLOW UP WITH THE HEALTHCARE PROFESSIONAL (HCP). IT WAS REVIEWED WITH THE PATIENT THAT IT WAS NOT RECOMMENDED THAT THE PATIENT CHANGE THE BATTERIES FOR THE ENS AND THAT THE PATIENT FOLLOW UP AS SOON AS HE CAN WITH HIS HCP THAT HE IS WORKING WITH FOR THE TRIAL. PATIENT NOTED DURING THE CALL THAT HE WAS CURRENTLY IN THE HOSPITAL AND THAT HIS DEVICE WAS NOT DOING ANY GOOD IF THE BATTERIES WERE DEPLETED. NO FURTHER

  Patient problems: Therapeutic Response, Decreased

  MAUDE report 7466052 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT(B)(6) 2018. IT WAS REPORTED THE TRIAL PATIENT STARTED HAVING PAIN ON (B)(6) FROM THE PROCEDURE AND WAS ADVISED TO CONTACT THEIR PHYSICIAN. ON (B)(6) THE PATIENT¿S FAMILY REPORTED PATIENT HAS PAIN AT THE INCISION SITE WHICH SEEMS TO BE SWOLLEN CAUSING AN INFECTION ALSO THAT PATIENT SEEMED TO HAVE NO URGENCY LEVEL FOR THE PAST 12 HOURS, WHICH WAS A CONCERN. THE PATIENT¿S PAIN AT THE INCISION HAD WORSENED OVER TIME. THE PATIENT WAS TAKING GENERIC VICODIN THAT IS NOT DOING THE JOB FOR THE PAIN; PATIENT CHOSE TO NOT USE IT AT FIRST AND BEGAN TAKING IT YESTERDAY. THE PATIENT LAST URINATED AT 3 AM AND HASN'T HAD THE URGE SINCE. THE PATIENT HAS THE TRIAL FOR INCONTINENCE AND TYPICALLY GOES 2-3X DURING THE DAY AND MAYBE A COUPLE TIMES AT NIGHT, WHERE SHE WOULD HAVE THE URGE BUT NOTHING WOULD HAPPEN. THE FAMILY MEMBER STATES IT APPEARS TO BE A POSITIVE CHANGE BUT IS UNSURE ABOUT IT. CALLER REPORTED DEVICE SETTING IS IN THE 2.2 MA RANGE. ON (B)(6) THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE PATIENT¿S PRIMARY CARE PHYSICIAN HAD RESTARTED THE PATIENT ON COUMADIN AND 24 HOURS LATER THE PATIENT WAS HOSPITALIZED FOR BLEEDING, MA

  Patient problems: Complaint, Ill-Defined; Fatigue; Hematoma; Hemorrhage/Blood Loss/Bleeding; Lethargy; Pain; Post Operative Wound Infection; Swelling; Weakness

  MAUDE report 7449212 ↗
• InjuryApr 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA AFTER THE PNE. PATIENT COMPLAINED OF PELVIC PAIN AND REPORTED A LOW PLATELET LEVEL (50000) PER PATIENT HBG 9.7. A CT SHOWED A LARGE ABDOMINAL HEMATOMA. NO ACTIONS HAD BEEN DONE AT THE TIME, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. IT WAS REPORTED THAT THE ISSUE WAS UNRESOLVED. PATIENT HAD NO COMPLAINTS PRIOR TO THE PNE. AFTER THE PATIENT CAME BACK TO THE DOCTOR, THEY INFORMED THEIR DOCTOR THAT THEIR PLATELETS WERE LOW PRIOR TO THE EXAM. SURGICAL INTERVENTION HAD NOT OCCURRED AND WAS NOT PLANNED. PATIENT HAD CALLED COMPLAINING OF PAIN POST PNE. PATIENT WAS ADVISED TO LOWER THEIR STIMULATION AND CONTACT THEIR DOCTOR. THE DOCTOR ADMITTED THEM TO THE HOSPITAL AND A CT SCAN SHOWED A LARGE PELVIC HEMATOMA. LABS SHOWED HGB OR 9.7. THE PATIENT WAS ADMITTED TO THE HOSPITAL AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

  Patient problems: Abdominal Pain; Complaint, Ill-Defined; Embolism; Extravasation; Hematoma; Hemorrhage/Blood Loss/Bleeding; Ischemia; Necrosis; Pain; Pseudoaneurysm; Test Result

  MAUDE report 7395409 ↗
• InjuryMar 30, 2018Failure to Deliver Energy; Failure to Deliver Energy

  INFORMATION WAS RECEIVED REGARDING A TRIAL PATIENT. MANUFACTURER REPRESENTATIVE REPORTED THE BASIC EVALUATION WAS PERFORMED WITH NOTHING OUT OF THE ORDINARY. WHEN THE PATIENT TURNED THEIR DEVICE UP TO ABOUT 3.0 THEY WERE NOT FEELING STIMULATION. THE PATIENT THEN HELD THE DOWN ARROW TO RETURN THE AMP TO 0.0. ONCE THAT WAS ACCOMPLISHED THE PATIENT ATTEMPTED TO STAND AND RESUME INCREASING THE ENS. HOWEVER THIS TIME, THEY APPEARED TO WHENCE IN PAIN AND ALMOST BUCKLED ON THEIR LEFT SIDE. THEY TRIED AGAIN TO SUPPORT THEIR WEIGHT WITH THEIR LEFT SIDE, BUT WAS UNSUCCESSFUL. AS TIME WENT ON, 10-15 MINUTES, PATIENT REPORTED THE SEVERITY INCREASED. A CT SCAN WAS PERFORMED AND IT WAS DETERMINED THAT THE PATIENT HAD ¿A SMALL PIRIFORMIS EMBOLISM.¿ IT WAS REPORTED THAT THE PATIENT WOULD BE GIVEN BOTH ANTIBIOTICS AND OVER THE COUNTER MEDS AND WOULD RESUME THE TRIAL IN A DAY OR TWO. NO CAUSE WAS KNOWN. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

  Patient problems: Embolism; Pain

  MAUDE report 7385269 ↗
• MalfunctionFeb 2, 2018Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Adverse Event Without Identified Device or Use Problem

  THE HCP REPORTED THAT THE LEAD DISLODGEMENT WAS NON APPLICABLE AND THAT THE LEAD WAS A TEST LEAD AND THEY MOVE. THE HCP REPORTED THAT THE ISSUE WAS RESOLVED AND THAT THE PATIENT WENT GET THE PERMANENT IMPLANT.

  Patient problems: Sleep Dysfunction; Twitching; Undesired Nerve Stimulation

  MAUDE report 7236868 ↗
• MalfunctionDec 7, 2017Migration or Expulsion of Device; Device Operates Differently Than Expected; Migration or Expulsion of Device; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS IMPLANTED FOR BASIC EVALUATION (BE). IT WAS REPORTED THAT THE TRIAL PATIENT¿S FREQUENCY HAD COME BACK AND TURNING UP THE STIMULATION CAUSED THEM PAIN. THERAPY SIDES WERE CHANGED. THE ISSUE WAS REPORTED AS NOT RESOLVED AT THE TIME OF REPORT. IT WAS UNKNOWN IF ANY SURGICAL INTERVENTION HAD OCCURRED OR WAS PLANNED. THE PATIENT STATUS WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE CAUSE OF THE PATIENT'S PAIN WHEN STIMULATION WAS INCREASED WAS THE WIRES MIGRATED SO THEY WERE REMOVED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION RECEIVED FROM THE REP WHO CLARIFIED THE "WIRES MIGRATED" WAS IN REFERENCE TO THE LEADS. DEVICE INFORMATION WAS PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Therapeutic Response, Decreased; Urinary Frequency / Polyuria

  MAUDE report 7094944 ↗
• MalfunctionDec 4, 2017Failure to Deliver Energy; Migration or Expulsion of Device; Device Displays Incorrect Message; Device Operates Differently Than Expected; Failure to Deliver Energy; Migration or Expulsion of Device; Device Displays Incorrect Message; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT THE PATIENT HAD NOT PASSED A BOWEL MOVEMENT SINCE THE PROCEDURE. THE PATIENT WAS NOT FEELING STIMULATION AND WHEN TRYING TO INCREASE THEY COULD NOT GET PAST 5.1. THE PATIENT RECEIVED THE ¿DESIRED SETTINGS NOT AVAILABLE MESSAGE¿. THE PATIENT SWITCHED TO THE LEFT AND WAS NOT ABLE TO FEEL STIMULATION AND INCREASE STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED ON 2017-NOV-14. IT WAS REPORTED BY THE HEALTH CARE PHYSICIAN (HCP) THAT THE LEADS MIGRATED AWAY FROM THE NERVE. THERE WERE NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

  Patient problems: Constipation; Therapeutic Effects, Unexpected

  MAUDE report 7081317 ↗
• InjuryNov 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED BY AN ADVANCED EVALUATION TRIAL PATIENT REGARDING AN EXTERNAL NEUROSTIMULATOR (ENS). PATIENT WAS STILL IN THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURE REPRESENTATIVE (REP) WHO SPOKE WITH THE PATIENT'S HEALTHCARE PROVIDER (HCP). ACCORDING TO THE HCP, THE PATIENT EXPERIENCED A COMPRESSION DUE TO PRONE POSITIONING AND ANESTHESIA. THE PATIENT EXPERIENCED SENSORY AND MOTOR DEFECT IN THEIR FACE SO THEY WERE KEPT OVERNIGHT. THEY WENT HOME THE NEXT DAY HAVING RETURNED TO BASELINE AND WAS IMPLANTED A WEEK LATER. NO DEVICE ISSUE AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 7070311 ↗
• InjuryNov 28, 2017Adverse 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 MANUFACTURE REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS) IT WAS REPORTED THE PATIENT WOULD NOT STOP BLEEDING AFTER THE TRIAL IN THE OFFICE. IT WAS NOTED THE PATIENT DID NOT STOP HER BLOOD THINNERS. THE REP NOTED THE HCP TRIED TO STOP THE BLEEDING AND SURGEON WAS BROUGHT INTO STITCH. IT WAS NOTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THERE WERE NO FURTHER COMPLICATIONS THAT HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7064263 ↗
• MalfunctionNov 9, 2017Migration or Expulsion of Device; Device Operates Differently Than Expected; Migration or Expulsion of Device; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT THE PATIENT¿S MIND WAS MIXED UP AT THE TIME OF THE CALL. THE PATIENT STATED THEY COULD LISTEN BUT NOT ¿UNDERSTAND WHAT WAS GOING ON OR UNDERSTAND¿. THE PATIENT REPORTED THAT THEY HAD NO CONTROL OF THEIR BLADDER THE NIGHT BEFORE OR THE DAY OF THE REPORT. THE PATIENT REPORTED THAT STIMULATION WAS AT 4.9 AND IT WAS UNCOMFORTABLE SO THEY LOWERED IT TO 3.7 AND IT WAS COMFORTABLE, IN THE CORRECT LOCATION, AND THEY WERE NO LONGER IN PAIN. ON (B)(6) 2017, THE PATIENT¿S HUSBAND REPORTED THAT ¿THIS THING WASN¿T WORKING¿. IT WAS REPORTED THAT THERE WAS NO IMPROVEMENT AND IT WAS WORSE THAN IT WAS BEFORE. THE PATIENT WAS GOING THROUGH 1 PAIR OF PANTS, BUT WAS NOW GOING THROUGH 2 PAIRS. THE PATIENT¿S HUSBAND WANTED THE DEVICE TO GIVE THE PATIENT THE SENSE OF URGE WHEN TO USE THE RESTROOM AND THE URGE THEY ONLY GOT AT NIGHT TIME. IT WAS NOTED THAT THE PATIENT NEEDED A SIGNAL AND THAT WAS NOT HAPPENING. ON 2017-OCT-16 IT WAS REPORTED THAT THE SYMPTOMS WERE THE SAME AND BEFORE THE EVAL, THEY COULD GO ALL DAY AND COULD GO AT CERTAIN TIMES. THE PATIENT NOW HAD TO CHANGE ¿2 TIME

  Patient problems: Complaint, Ill-Defined; Discomfort; Incontinence; Pain; Urinary Frequency / Polyuria

  MAUDE report 7014260 ↗
• MalfunctionNov 7, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected; Device Displays Incorrect Message; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR FOR ADVANCED EVALUATION. IT WAS REPORTED THAT PATIENT TRIED TO INCREASE STIMULATION AND RECEIVED THE CANNOT PROVIDE DESIRED SETTINGS AT 5.2. THEY CHANGED TO PROGRAM 2 AND GOT THE SAME MESSAGE AT 3.5. ON PROGRAM 3 THEY RECEIVED THE MESSAGE AT 2.3. THERE WERE NO KNOWN CONTRIBUTING FACTORS TO THIS EVENT. FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT WAS STILL SEEING THE UNABLE TO PROVIDE DESIRED SETTINGS SCREEN. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER. IT WAS REPORTED THAT THE EVALUATION WAS NOT HELPING AT ALL AND THE PATIENT WAS NOT SEEING IMPROVEMENTS. THE PATIENT HAD SOME CONTRACTIONS AND THERE WAS DISCHARGE YESTERDAY, BUT NONE ON THE DAY OF THE REPORT. THE PATIENT WANTED TO GO OVER PROGRAMS AND STIMULATION; IT WAS NOTED THE PATIENT WAS TOLD TO INCREASE IT THREE TIMES A DAY. ADDITIONAL INFORMATION WAS RECEIVED THREE DAYS LATER. IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING AND IT WAS CLARIFIED THAT IT WAS THE MORE THE THERAPY ITSELF. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIV

  Patient problems: Discharge; Muscle Spasm(s)

  MAUDE report 7006925 ↗
• InjuryOct 30, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REITERATED THAT THE PATIENT¿S PAIN AND DISCOMFORT DID NOT SUBSIDE WITH THE NEW ENS SO IT WAS ASSUMED THAT IT WAS NOT CAUSED BY THE ENS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT INFORMED THE NURSING STAFF THAT THEY WERE IN A CAR ACCIDENT JUST BEFORE THE TRIAL STARTED THAT MAY HAVE CONTRIBUTED TO THEIR PAIN. NO FURTHER PATIENT COMPLICATIONS ARE ANTICIPATED OR EXPECTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Discomfort; Numbness; Pain; Urinary Retention

  MAUDE report 6987145 ↗
• InjuryAug 18, 2017Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN ADVANCED EVALUATION TRIAL PATIENT. THE REP REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION DUE TO A PROLONGED ADVANCED EVALUATION. THE RISKS OF PROLONGING THE EVALUATION WERE DISCUSSED WITH THE PHYSICIAN AND PATIENT BY THE REP. HOWEVER, BOTH THE PHYSICIAN AND PATIENT ELECTED TO PROLONG THE TEST. AS A RESULT, AN INFECTION OCCURRED WHICH WAS LIKELY DUE TO THE TIME OF THE TEST. THE TEST WAS 7 WEEKS LONG WHICH WAS 5 WEEKS BEYOND MEDTRONIC AND FDA PROTOCOL. IT WAS INDICATED THAT THE PATIENT CONTINUED TO WORK DAILY AND AS A RESULT WOULD PERSPIRE THROUGHOUT THE DAY. THE PATIENT CHANGED THEIR DRESSING AT HOME SEVERAL TIMES AGAINST INITIAL DIRECTION AND IT WAS ASSUMED THAT BACTERIA WAS INTRODUCED TO THE SITE BECAUSE OF THIS. THE REP NOTED THAT THEY WERE PRESENT IN THE OFFICE, ON OR ABOUT ON (B)(6) 2017, WHEN THE PATIENT WAS SEEN BY THE HCP AS A FOLLOW-UP TO THEIR INITIAL STAGE ONE. THE REP NOTED THAT THE PATIENT INFORMED THEM THAT THEY HAD ALREADY REDRESSED THE PERCUTANEOUS LEAD SITE AND THAT THEIR SON HAD ACCIDENTLY CUT THE TWIST LOCK CABLE. THE CABLE WAS REPLACED AND RE-DRESSED BY THE STAFF ON SITE. THE RISK

  Patient problems: No Known Impact Or Consequence To Patient; Unspecified Infection

  MAUDE report 6805768 ↗
• MalfunctionAug 8, 2017Device Displays Incorrect Message; Device Operates Differently Than Expected; Improper Device Output; Device Displays Incorrect Message; Device Operates Differently Than Expected; Improper Device Output

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A TRIAL PATIENT WHO HAS AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THEY WERE TRYING TO CHANGE THEIR DRESSING AND BROKE THE WIRE COMING OUT OF THEIR BODY. THE PATIENT STATED THERE WERE ABOUT TWO INCHES OF THIN WIRE THAT WERE STICKING OUT OF THEIR SKIN. THE PATIENT TIRED TO TURN THEIR STIMULATION OFF BUT REPORTED SEEING A CANNOT PROVIDE YOUR DESIRED SETTINGS - CALL YOUR CLINICIAN ON THE CONTROLLER AND WAS UNABLE TO TURN THE STIMULATION OFF AND NOTED THE CONTROLLER JUST VIBRATED. THE PATIENT WAS TO FOLLOW UP WITH THEIR HEALTHCARE PROFESSIONAL (HCP). NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6774395 ↗
• MalfunctionJul 31, 2017Failure to Deliver Energy; Migration or Expulsion of Device; Failure to Deliver Energy; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT WITH TRIAL DEVICE SYSTEM WHICH STARTED TODAY. THE FAMILY MEMBER REPORTED THE TRIAL PATIENT DID NOT FEEL THE STIMULATION. THERE WAS NOT A CHANGE IN THERAPY RELATED TO POSITIONAL MOVEMENT. ALSO, NO FALLS OR TRAUMA WERE REPORTED THAT COULD BE RELATED TO THE ISSUE. THE STIMULATION ON THE RIGHT SIDE HAD BEEN INCREASED UP TO 9.0 BUT THE PATIENT DID NOT FEEL THE STIMULATION. THE STIMULATION WAS CHANGED TO THE LEFT SIDE BUT THE PATIENT DID NOT FEEL THE STIMULATION WHEN TURNED UP TO AS HIGH AS IT WOULD GO. USING THE PROGRAMMER, IT WAS REPORTED THE THERAPY WAS ON BUT THE TRIAL PATIENT DID NOT FEEL THE STIMULATION IN THE CORRECT BIKE SEAT AREA. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURE REPRESENTATIVE (REP). THE CAUSE OF NOT FEELING STIMULATION ON EITHER SIDE WAS DETERMINED. THE PATIENT IS OBESE AND THE WIRES MIGRATED OUT OF THE FORAMEN BEFORE THE PATIENT LEFT THE HOSPITAL. AS A RESULT OF THE LEAD MIGRATION, THE PATIENT IS MOVING ONTO THE ADVANCED EVALUATION. THE NOT FEELING STIMULATION ISSUE WAS RESOLVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 6753831 ↗
• InjuryJun 29, 2017Intermittent Continuity; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem; Intermittent Continuity; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER (CON) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT IT WAS NOT WORKING AT ALL. IT WAS NOTED THAT THE HANDHELD CONTROLLER WASN'T WORKING AND THEY WERE UNABLE TO URINATE. IT WAS ALSO REPORTED THAT THE DEVICE WAS TURNING OFF, SO IT COULDN'T BE FOUND BY THE CONTROLLER. ON (B)(6) 2017, IT WAS REPORTED THAT, IN THE OFFICE, THE REP TRIED REPLACING THE BATTERIES AND REPOSITIONING THE BATTERIES. EVERY TIME THEY WOULD, THE DEVICE WOULD COME ON FOR 20 SECONDS AND SHUT DOWN AGAIN. THE EXTERNAL NEUROSTIMULATOR (ENS) WAS REPLACED AND THE PATIENT'S THERAPEUTIC BENEFIT RETURNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: Urinary Retention

  MAUDE report 6678518 ↗
• MalfunctionJun 29, 2017Break; Device Operates Differently Than Expected; Break; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT. IT WAS REPORTED THAT THE REP WAS UNABLE TO INCREASE THE AMPLITUDE ABOVE 0.1 VOLTS (V). THEY HAD THE SAME PROBLEM ON BOTH SIDES. THE REP CHECKED ALL THE CONNECTIONS, NOTING THAT THEY LOOKED FINE. THEY WERE UNABLE TO TROUBLESHOOT AT THE TIME OF THE REPORT. ON (B)(6) 2017, IT WAS REPORTED THAT, AFTER FURTHER EXAMINATION FROM THE NURSE PRACTITIONER (NP), THEY WERE MADE AWARE THAT THE PATIENT BROKE THEIR LEFT LEAD. IT WAS NOTED THAT THE RIGHT SIDE WAS NOT AFFECTED AND THE NP WAS ABLE TO HOOK UP THE RIGHT LEAD WITH A UNILATERAL CORD, WHICH THE PATIENT TESTED FOR ANOTHER TWO DAYS. THE TRIAL WAS SUCCESSFUL AND THE PATIENT WAS GOING TO THE IMPLANT IN (B)(6) 2017. THERE WERE NO SYMPTOMS OR FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6676365 ↗

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-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
• 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