Verify® 353101 (UDI 00763000640491)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00763000640491), received between Sep 24, 2022 and Jan 3, 2025 — classified as 12 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (7 reports).

5 other recalls cover devices cleared under the same FDA submission (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE TRIAL WAS INITIATED ON (B)(6) 2024. IT WAS REPORTED THAT SINCE RECEIVED THE TRIAL IMPLANT TODAY HADN'T BEEN ABLE TO URINATE AT ALL AND SAID THAT WAS SO USED TO GOING FREQUENTLY. CALLER SAID THAT THEY LEFT A MESSAGE HOWEVER HAVEN'T RECEIVED A CALL BACK YET FROM THE MANUFACTURER REPRESENTATIVE (REP). REVIEWED THERAPY INFORMATION AND GENERAL PROGRAMMING GUIDANCE. CALLER SAID THAT THEY DON'T FEEL COMFORTABLE MAKING ANY ADJUSTMENTS. PATIENT WILL MAINTAIN STIMULATION LEVEL AND WILL CONTINUE TO TRACK SYMPTOMS. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO CHECK IF THERE WAS AN ANSWERING SERVICE TO NOTIFY ON-CALL HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. EMAIL WAS SENT TO FIELD STAFF.

  Patient problems: Urinary Frequency / Polyuria; Urinary Retention

  MAUDE report 21064720 ↗
• MalfunctionSep 2, 2024Break; Difficult to Remove; Break; Difficult to Remove

  ADDITIONAL INFORMATION WAS RECEIVED ON 2024-SEP-24. INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT (PT) WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE LEAD PULLED AFTER TRIAL AND "JUST THE ELECTRODE BROKE OFF" AND CANNOT BE RETRIEVED. CALLER INQUIRED IF THIS AFFECTS PT'S SCAN ELIGIBILITY. WHEN ASKED IF THE EVENT HAD BEEN REPORTED ALREADY, CALLER NOTED THAT THEY WERE NOT SURE AND THEY WERE FOLLOWING UP ON THIS FOR ANOTHER REP BUT STATED THEY WOULD BE SURE TO HAVE THEM REPORT IT. CALLER ALSO STATED THAT THE REP CALLED TECHNICAL SERVICES ABOUT THIS ISSUE ALREADY AND MAY HAVE ALREADY SUBMITTED AN MPXR. DURING CALL, REP ALSO MADE THE STATEMENT, TECHNICAL STIM SERVICE (TSS) SENT FOLLOW-UP EMAIL REGARDING THIS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP STATING THAT THEY NEVER HAD A PERIPHERAL NERVE EVALUATION (PNE) LEAD BREAK IN THEIR TERRITORY. AS STATED, THEY CALLED ON BEHALF OF A COLLEAGUE THAT REPORTED THIS INCIDENT. THEY HAVE HEARD S TORIES OF THE PNE LEADS BREAKING DURING PULLS FROM COLLEAGUES AT OUR DEPARTMENT (NHM). ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURE

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20116606 ↗
• MalfunctionJul 25, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. THE TRIAL STARTED ON 2024-07-02. IT WAS REPORTED THAT THE LEAD MIGRATED AND PATIENT HAD A LOSS OF THERAPY. AN EXTERNAL DISCONNECTION WAS ALSO REPORTED. CAUSE WAS UNKNOWN. THE ISSUE WAS ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 19828581 ↗
• InjuryJul 24, 2024Break; Difficult to Remove; Break; Difficult to Remove

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE. IT WAS REPORTED THAT WHEN THIS PATIENT RETURNED TO THEIR PHYSICIAN FOR HER LEAD PULL (B)(6) 2024, THE LEFT LEAD WAS CUT TO THE POINT THE PHYSICIAN COULD NOT SEE ANYTHING OUTSIDE OF THE SKIN. WHEN X-RAYED, THE TRIAL LEAD WAS STILL INSIDE THE PATIENT, VERY DEEP WITHIN THE FOREMAN. PHYSICIAN ATTEMPTED REMOVAL BY DISSECTING DOWN, WITHOUT SUCCESS DUE TO THE DEPTH OF THE LEAD. THEY CANNOT GET A FRAGMENT OF THE LEAD WIRE OUT. WIRE REMAINS IN PATIENTS. TECHNICAL SERVICES (TS) REVIEWED IT IS A MEDICAL DECISION ON WHAT TO DO.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19819835 ↗
• InjuryJul 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL(HCP). IT WAS REPORTED THAT THE PATIENT HAD PERIPHERAL NERVE EVALUATION (PNE) ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT HAD NO IMPROVEMENT AND DECLINED STAGE 1 EVALUATION. THE ISSUE WAS NOT RESOLVED.

  Patient problems: Insufficient Information; Urinary Retention

  MAUDE report 19701009 ↗
• InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE STEPS THAT WERE TAKEN TO RESOLVE THE ISSUE WERE NOTED AS BEING "AMPLITUDE INCREASED." THE HCP ALSO NOTED THAT THE ISSUE HAS BEEN RESOLVED.

  Patient problems: Urinary Retention

  MAUDE report 19615600 ↗
• InjuryMay 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE ERROR MESSAGES AND TEST FLOW ERRORS WERE NOT SPECIFICALLY DETERMINED, BUT BY PROCESS OF ELIMINATION, THE PERCUTANEOUS EXTENSION APPEARED FAULTY. ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19355371 ↗
• MalfunctionMay 15, 2024Failure to Deliver Energy; Migration or Expulsion of Device; Failure to Deliver Energy; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE. IT WAS REPORTED THAT THE PATIENT'S TRIAL STARTED ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT REPORTED THEY HAD A LEAD MIGRATION AND A LOSS OF THERAPY. THE PATIENT WAS IN THE ER FOR THE LEAD WIRE THAT CAME OUT. IT IS UNKNOWN IF THE ISSUE WAS RESOLVED.

  Patient problems: Insufficient Information

  MAUDE report 19319108 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  2024-DEC-09 LFC (HCP): ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP). THE HCP CONFIRMED THAT THERE WAS NO DIFFICULTIES ENCOUNTERED WITH THE TRIAL PROCEDURE. THE PATIENT WAS NOT ON BLOOD THINNERS PRIOR TO THE PROCEDURE. THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH CLOTTING DISORDER AND WAS PERMANENTLY ON MEDICATION. THE HCP CONFIRMED THAT THE PATIENT WAS PROVIDED TREATMENT WITH CONSERVATIVE ANTIBIOTICS. WHEN ASKED ABOUT THE CURRENT STATUS OF THE PATIENT, THE HCP STATED THAT THE PATIENT WAS CURRENTLY DOING ANTIBIOTICS AND FOLLOWED BY CT SCANS.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 19291775 ↗
• MalfunctionMay 1, 2024Migration or Expulsion of Device; Communication or Transmission Problem; Migration or Expulsion of Device; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGENCY FREQUENCY AND URGE INCONTINENCE. IT WAS NOTED THAT THE PATIENTS TRIAL STARTED ON 2024-MAR-04. IT WAS REPORTED THAT THE PATIENT HAD INTERMITTENT, DIFFICULT, OR SPORADIC COMMUNICATION. ADDITIONAL INFORMATION WAS RECEIVED ON 2024-MAR-09 , PATIENT ENS BATTERY NEEDS TO BE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THAT THE CAUSE OF THE INTERMITTENT COMMUNICATION WAS DETERMINED TO BE DUE TO THE PNE LEADS WERE COMPLETELY REMOVED BY THE PATIENT DURING THE TRIAL. PATIENT HAS A HISTORY OF DEMENTIA. THEY WERE SEEN ON 2024-MAR-11 AND DECIDED NOT TO PROCEED WITH PERMANENT IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19219881 ↗
• InjuryApr 18, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP). THE HCP REPORTED TO RESOLVE THE ISSUE WITH THE LEAD MIGRATION THE LEAD WAS REPLACED DURING STAGE 2. THE ISSUE HAS BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140345 ↗
• MalfunctionMar 17, 2024Break; Break

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE I NCONTINENCE AND URGENCY FREQUENCY, IT WAS REPORTED THAT THEIR TRIAL BEGAN ON (B)(6) 2024. IT WAS REPORTED THAT THEY WERE REPORTING ISSUES WITH A BROKEN LEAD, LEAD DAMAGED, OR LEAD CUT. THEY NOTED THE INNER STYLET WAS NOT SEATED WHEN REMOVED FROM THE TUBE. THE PHYSICIAN TRIED TO FIX IT BUT WAS UNABLE TO. THE TIP WAS DISTENDED AND BENT. THE CAUSE OF THE ISSUE WAS NOTED TO BE DUE TO THE INNER STYLET NOT BEING SEATED WHEN REMOVED FROM THE TUBE. THE ISSUE WAS REPORTED AS BEING RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18919173 ↗
• MalfunctionDec 6, 2023Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Environmental Compatibility Problem; Patient Device Interaction Problem; Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Environmental Compatibility Problem; Patient Device Interaction Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. IT WAS NOTED THAT THE PATIENTS TRIAL STARTED ON (B)(6) 2023 . IT WAS REPORTED THAT THE PATIENT EXPERIENCED STIM IN WRONG LOCATION DUE TO PATIENT MO VEMENT/ACTIVITY/ACCIDENT. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) ON (B)(6) 2023. WHEN ASKED WHAT THE CAUSE OF THE STIMULATION BEING FELT IN THE WRONG LOCATION THEY STATED THAT ONE LEAD HAD LIKELY MIGRATED AWAY FROM THE NERVE. WHEN ASKED WHAT STEPS WOULD BE TAKEN TO RESOLVE THE ISSUE THEY STATED THAT THE LEAD WAS NO LONGER USED AND THE OPPOSITE WAS STIMULATED INSTEAD. THIS HAD BEEN RESOLVED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 18277395 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS. THE REP REPORTED THAT THE PATIENT TESTED FOR 2 WEEKS BUT ENDED UP INFECTED. THE PATIENT WAS HAVING SEEPAGE FROM THEIR POCKET SITE. THE PHYSICIAN DECIDED TO CANCEL THEIR STAGE 2, TAKE EVERYTHING OUT, AND GIVE THEM A COUPLE MONTHS TO RECOVER. THEN THEY WILL DO THE FULL IMPLANT.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 18273803 ↗
• MalfunctionNov 21, 2023Break; Display or Visual Feedback Problem; Break; Display or Visual Feedback Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE PATIENT'S TRIAL BEGAN ON (B)(6) 2023. IT WAS REPORTED THAT THE REP SAID PATIENT REPORTED SEEING CONNECT THE LEAD MESSAGE ON THE PATIENT'S DEVICE. REP SAID THEY HAD PATIENT DISCONNECT THE ENS AND TRIED AGAIN, BUT GOT THE SAME MESSAGE. TECHNICAL SERVICES(TS) TOLD REP TO CONFIRM THERE IS NO MOISTURE IN THE ENS, AND IF POSSIBLE REPLACE IT. IF ISSUE IS STILL THERE, THEN THE LEAD/EXTENSION SITE MIGHT HAVE A DISCONNECTION. REP SAID THEY GOT MESSAGE FROM PATIENT ON FRIDAY, BUT DIDN'T KNOW WHAT THE ISSUE WAS UNTIL YESTERDAY. REP DIDN'T KNOW IF ISSUE STARTED FRIDAY OR SATURDAY. THE CALLER WAS NOT WITH THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE PATIENT SEEING "CONNECT THE LEAD" MESSAGE WAS DETERMINED DUE TO PATIENT PERCUTANEOUS CONNECTION CORD WAS CUT. PATIENT IS GETTING DEVICE IMPLANTED ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18186304 ↗
• MalfunctionNov 16, 2023High impedance; High impedance

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. IT WAS REPORTED THAT DURING PROCEDURE, ELECTRODE ZERO OVER 4K; TAKEN OUT OF BATTERY TO CLEAN 3X AND REINSERTED WITH SAME ISSUE; TESTED LEAD WITH TESTING CABLE AND DISCOVERED NO MOTOR RESPONSE ON ELECTRODE ZERO EVEN THOUGH IT WAS WORKING PROPERLY WHEN TESTING INITIALLY. RECHECKING IMPEDANCES AFTER CLEANING LEAD 3 TIMES, RETESTING WITH TESTING CABLE WITH NO MOTOR RESPONSE ON ELECTRODE 0.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18147889 ↗
• InjurySep 27, 2023Break; Difficult to Remove; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER AND A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT REP FOUND OUT YESTERDAY, (B)(6) 2023. THAT THE PATIENT HAD A HIGH FEVER AT THE STAGE 2 SO THE LEAD WAS EXPLANTED. PATIENT HAD A SUCCESSFUL STAGE 1 SO WILL HAVE THE FULL IMPLANT RESCHEDULED FOR DECEMBER. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023, THE PATIENT HAD FECAL DISCHARGE.

  Patient problems: Fecal Incontinence; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824234 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR NON-OBSTRUCTIVE URINARY RETENTION. IT WAS NOTED THAT THE PATIENT¿S TRIAL STARTED ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT (PT) BECAME LIGHT-HEADED AND DIZZY THE NIGHT OF THE PROCEDURE. THEY FELL ON THEIR BACKSIDE, RIGHT WHERE THE TRIAL PROCEDURE WAS DONE. THEY WENT TO THE HOSPITAL AND WERE TREATED FOR PAIN IN THAT AREA. THEY WERE DISCHARGED THE FOLLOWING DAY, BUT CONTINUED TO HAVE PAIN. THEY WERE READMITTED TO THE HOSPITAL ON(B)(6) 2023 WITH PAIN IN THE SAME AREA. THE PAIN WAS ACROSS THE LOWER BACK WHERE THE PROCEDURE STAGE 1 AS PERFORMED. THE PATIENT HAD A LIDOCAINE PATCH ON THAT AREA AND WERE STILL IN PAIN. THE HCP MADE THE DECISION TO REMOVE THE DEVICE AND CANCEL THE TRIAL. STAGE 1 WAS REMOVED WITHOUT COMPLICATION. THE PATIENT WILL MOST LIKELY NOT HAVE ANOTHER TRIAL.

  Patient problems: Dizziness; Fall; Pain

  MAUDE report 16564424 ↗
• MalfunctionFeb 28, 2023Migration 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

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE STAGE 1 LEAD WAS PULLED AND THEN STAGE 2 WAS A COMPLETE REPLACED OF LEAD AND IMPLANT OF THE BATTERY.

  Patient problems: Constipation; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 16452258 ↗
• InjuryFeb 6, 2023Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EXTERNAL COMPONENT. IT WAS REPORTED THAT THE CALLER FINISHING EVALUATION AND ENS IS NOT RECOGNIZING CABLE - IT SEES IT AS TEST STIM STILL. CALLER HAD TRIED DIFFERENT HANDSETS AND ON 4TH ENS WITH SAME RESULTS. WILL SPEAK TO THE DOCTOR TO GET CABLE REPLACED.  REP SAID ISSUE WAS RESOLVED WHEN HE USED A NEW HANDSET AND ENS. REP SAID HE HAD ALSO REPLACED THE EXTENSION. HE ALSO OPENED A LEAD KIT TO GET THE TUNNELLER. ON (B)(6) 2023 THE MANUFACTURER REPRESENTATIVE (REP) SUPPORTED A STAGE I INTERSTIM PROCEDURE. THE REP ARRIVED AND WENT TO PRE-OP TO TEACH THE PATIENT HOW TO USE THE DEVICE AND ANSWER QUESTIONS SHE HAD. THE REP GRABBED THE ENS AND AN OLDER MODEL SAMSUNG PHONE AND BONDING THE TWO USING A VERIFY SIMULATOR. THIS ALLOWS REP TO DEMO THE DEVICE BEFORE THE PATIENT HAS SEDATION SO SHE WILL RETAIN THE EDUCATION. REP ENTERED 7 PROGRAMS INTO THE ENS AND THEN WALKED THE PATIENT THRU USING THE SAMSUNG TO ADJUST HER STIMULATION. AFTER REP SWITCHED THE VERIFY SIMULATOR MODE INTO TEST STIM CABLE MODE SO IT WOULD BE READY TO RUN STIMULATION INTRAOPERATIVELY. ONCE THE PROCEDURE STARTED WE GOT GREAT LEAD PLACEMENT. ALL 4 E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16304736 ↗
• InjuryNov 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE AND URGENCY FREQUENCY. IT WAS NOTED THE PATIENT'S TRIAL STARTED ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL (B)(6) 2022. MENTIONED THEY WERE VERY SICK AND HAD DIARRHEA. CONDITION WAS IMPROVING. MAY HAVE BEEN DISCHARGED (B)(6) 2022 OR (B)(6) 2022. (B)(6) 2022 NO NEW INFORMATION

  Patient problems: Diarrhea; Malaise

  MAUDE report 15857044 ↗
• MalfunctionNov 4, 2022Migration 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

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE LEADS WILL BE REMOVED ON (B)(6)2022. THE LEADS HAD NO INDICATION THAT THEY HAD MOVED. THE ISSUE HAS BEEN RESOLVED.

  Patient problems: Discomfort

  MAUDE report 15728403 ↗
• MalfunctionNov 4, 2022Failure to Deliver Energy; Failure to Deliver Energy

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR INCONTINENCE. IT WAS NOTED THAT THE PATIENT'S TRIAL BEGAN ON (B)(6) 2022. IT WAS REPORTED THAT THE CALLER SAID "THE LADY" THAT CALLS THEM IS FOREIGN AND THEY ARE HEARING IMPAIRED, AND DOESN'T UNDERSTAND THE PATIENT. PATIENT SAID, THE DEVICE WAS OFF FROM 5PM SATURDAY UNTIL 5PM SUNDAY. THEY DIDN'T REALIZE IT WAS OFF. PATIENT JUST KEPT GOING TO THE BATHROOM AND THOUGHT THEY WOULD HAVE TO TURN THE THERAPY UP. PATIENT HAS NO IDEA HOW THE THERAPY GOT SHUT OFF. THE PATIENT HAD THE HANDSET LAYING ON THE COFFEE TABLE AND THEN WENT TO BED. THERE IS NOBODY AT PATIENT'S HOME BUT THEM, PATIENT LIVES ALONE. PATIENT ITCHED LIKE CRAZY SATURDAY AND SUNDAY. PATIENT STILL ITCHES TODAY BUT NOT QUITE AS BAD. IF PATIENT GET'S UP AND MOVES AROUND IT ITCHES. PATIENT CLARIFIED THE ITCHING IS JUST ON THEIR BACK, NOT INSIDE. PATIENT "HAS IT TAPED TO THEIR BACK." AGENT ASKED IF PATIENT IS ALLERGIC TO THE TAPE AND THEY SAID NO. BEFORE SATURDAY, BEFORE THE ENS GOT SHUT OFF, THEY WEREN'T HAVING AS MANY VOIDS AND NOT HAVING TO CHANGE THEIR DEPENDS. PATIENT GOT THE TRIAL FOR INCONTINENCE. TODAY THEY WERE GOING TO THE

  Patient problems: Incontinence; Itching Sensation; Urinary Frequency / Polyuria

  MAUDE report 15725555 ↗
• MalfunctionSep 24, 2022Display or Visual Feedback Problem; Failure to Interrogate; Communication or Transmission Problem; Display or Visual Feedback Problem; Failure to Interrogate; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT THE CALLER STATED THEY WERE UNABLE TO CONNECT TO ENS AFTER PLACING A STAGE 1 LEAD. CALLER INQUIRED IF RELATED TO ENS. CALLER CONFIRMED THE GREEN LIGHT WAS ON THE ENS, BUT NO BLINKING BLUETOOTH LIGHT. CALLER RECEIVED A MESSAGE ENTERING THE APP, AND SELECTING ENS, "SYSTEM ERROR, THE THERAPY DEVICE MAY HAVE STOPPED AND MAY NEED TO BE REPLACED." TROUBLESHOOTING SUGGESTED TURNING ON AND OFF AIRPLANE MODE TO RESET BLUETOOTH, WHICH DID NOT RESOLVE THE ISSUE. CALLER WAS ABLE TO REPLACE THE ENS AND RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15478547 ↗

Recalls under the same FDA submission

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

• 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-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