Verify® External Neurostimulator 353101Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00763000344573), received between Mar 18, 2021 and Sep 24, 2024 — classified as 24 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (30 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2024Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE HEALTHCARE PROVIDER (HCP) STATED THAT STAGE 2 WAS COMPLETED. THE X-RAY USED DURING STAGE 2 CONFIRMED THAT THE ACTUAL LEAD REMAINED IN GOOD POSITION DESPITE THE PATIENT PULLING ON THE WIRE/CUTTING THE WIRE. THE ISSUE WAS RESOLVED. STAGE 2 WAS COMPLETED ON (B)(6) 2024. THE X-RAY INTRA-OP CONFIRMED GOOD LEAD PLACEMENT AND NO RESIDUAL WIRE FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289643 ↗
• MalfunctionSep 9, 2024Break; Unintended Collision; Adverse Event Without Identified Device or Use Problem; Break; Unintended Collision; 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. THE TRIAL BEGAN ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT HAD BROKEN LEAD, LEAD DAMAGED, OR LEAD CUT. IT WAS REPORTED THAT A THIN PIECE OF THE DEVICE BROKE OFF AND FELL INTO WATER. THE CAUSE WAS KNOWN WHICH WAS A FALL IN THE BATHROOM. THE PATIENT WAS ALSO EXPERIENCING SUSPECTED INFECTION. THE ISSUE RESOLVED WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 20166909 ↗
• MalfunctionJul 25, 2024Break; Display or Visual Feedback Problem; Failure to Interrogate; Stretched; Communication or Transmission Problem; Break; Display or Visual Feedback Problem; Failure to Interrogate; Stretched; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URGE INCONTINENCE, URGENCY FREQUENCY. THE TRIALSTARTED ON (B)(6) 2024. IT WAS REPORTED THAT THERE WAS A COMMUNICATION ISSUE BETWEEN THE CONTROLLER AND ENS. PATIENT KEPT HITTING RETRY AND TURNED THE THERAPY OFF THEN BACK ON. NOTHING HELPED RESOLVED THE ISSUE AND THE COMMUNICATION ERROR THAT SHOWED STATED THAT THE DEVICE WAS NOT SET UP CORRECTLY. CAUSE WAS NOT DETERMINED. PATIENT REPORTED PAIN AND DISCOMFORT/SORENESS/PINCHING. THE ISSUE WAS ONGOING. PATIENT'S DEVICE IS GIVING A COMMUNICATION ERROR MESSAGE. TAPPING RETRY WILL NOT WORK. THE REP REPORTED THE RIGHT SIDED PNE LEAD WAS BROKEN JUST A FEW MM OUTSIDE OF SKIN AT NEEDLE ENTRY POINT. THERE WAS SOME STRETCHING AT SKIN SIGHT, BUT LEAD WAS HANGING,COILED TIGHTLY, STILL PLUGGED INTO THE RED PT CABLE CONNECTION. DRESSING WAS ORIGINAL ONE FROM ONE INSERTION AND INTACT. PT DENIES ANY BLUNT OR SHEARING FORCE AT ENTRY SITE. CAUSE WAS NOT DETERMINED. THE ISSUE WAS CONFIRMED RESOLVED.

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

  MAUDE report 19830932 ↗
• InjuryMay 7, 2024Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE MIGHT BE DUE TO POTENTIAL PATIENT MOVEMENT DURING THE TRIAL LEADING TO MIGRATION AND THAT THE LEAD WAS NOT BROKEN, THE TINES MAY HAVE BEEN WEAK, THE LEAD WAS INTACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260724 ↗
• MalfunctionApr 5, 2024Migration or Expulsion of Device; Communication or Transmission Problem; Insufficient Device Problem Information; Migration or Expulsion of Device; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR THE TREATMENT OF BLADDER ISSUES. IT WAS REPORTED THAT THE REASON FOR CALL WAS TO RECEIVE EDUCATION AS WASN'T SURE WHAT THEY WERE SUPPOSED TO DO, SAID RECEIVED TRIAL IMPLANT YESTERDAY MORNING. PATIENT SAID WAS STILL RECOVERING FROM ANESTHESIA WHEN INFORMATION WAS REVIEWED. PATIENT SAID WAS TOLD THAT MEDTRONIC REPRESENTATIVE, IS SUPPOSED TO CALL PATIENT TODAY. REVIEWED TRIAL INFORMATION AND REVIEWED GENERAL USE OF HANDSET. WHEN TRIAL PATIENT ATTEMPTED TO CONNECT RECEIVED COMMUNICATION ERROR, THAT SYSTEM NOT PROPERLY SET UP. EMAIL WAS SENT TO FIELD REP. PATIENT WAS ALSO DIRECTED TO PROVIDE UPDATE TO MANAGING PHYSICIAN'S OFFICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE OF THE COMMUNICATION ERROR STATING THAT SYSTEM WAS NOT PROPERLY SET UP WHEN THE PATIENT ATTEMPTED TO CONNECT, WAS BECAUSE THE PATIENT¿S RIGHT LEAD CAME DISCON NECTED FROM THE HUB. THIS MADE THE SETUP CONFIGURATION OF TWO LEADS NO LONGER POSSIBLE. HAD TO RE CONFIGURE IN THE CLINICIAN APP FOR ONLY ONE LEAD. THE MOST LIKELY CONTRIBUTING FACTOR WAS THE PATIENT ATTE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053640 ↗
• MalfunctionFeb 29, 2024Migration 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 A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR THERAPY. THE REP REPORTED THAT A WOUND CHECK. ON EXAM, THE EXIT POINT WHERE THE EXTERNAL WIRE IS HAD BECOME EXPOSED. SITE WAS CLEANED WITH BETADINE AND NEW DRESSING APPLIED. A NEW DRESSING WAS ALSO APPLIED OVER THE BATTERY. IT WAS RELATED TO DEVICE AND THERAPY AND RECOVERED/RESOLVED ON: (B)(6) 2024.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 18812400 ↗
• InjuryDec 6, 2023Failure to Deliver Energy; Impedance Problem; Failure to Deliver Energy; Impedance Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE I NCONTINENCE. IT WAS NOTED THAT THE PATIENT'S TRIAL STARTED ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF STIMULATION. THE CAUSE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. THIS INCLUDED THE PATIENT REPORTING THE DEVICE HAD TURNED OFF SO THEY WENT THROUGH THE SYSTEM AND DETERMINED THEY HAD IMPEDANCE ISSUES DURING THEIR TRIAL. THEY ADJUSTED TO A NEW PROGRAM AND COMMUNICATED WITH THE PHYSICIAN. IMPEDANCE WAS ON ELECTRODE 0 AND 1 ON NOV 18TH. THEY MOVED TO ELECTRODE 3 AND 4 AND THERE WERE NO ISSUES. THE PATIENT EXPERIENCED A RETURN TO THEIR BASELINE SYMPTOMS. THIS ISSUE WAS ON GOING.

  Patient problems: Insufficient Information

  MAUDE report 18278663 ↗
• InjuryNov 28, 2023Adverse 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. IT WAS NOTED THAT THE PATIENTS TRIAL STARTED ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND NEW URINARY RETENTION OF URINARY RETENTION. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED.

  Patient problems: Pain; Urinary Retention

  MAUDE report 18216040 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE PATIENT RECOVERED ON (B)(6) 2023.

  Patient problems: Apnea

  MAUDE report 18191314 ↗
• MalfunctionNov 14, 2023Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area; Migration or Expulsion of Device; Therapy Delivered to Incorrect Body Area

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR BLADDER ISSUES. IT WAS REPORTED THAT THE TRIAL HAD BEEN VERY CONFUSING FOR THEM. THE PATIENT STATED THEY'D BEEN TOLD BY A REPRESENTATIVE THAT THEY WERE SUPPOSED TO TURN IT UP AND DOWN AND PLAY WITH IT AND TRY TO FIGURE OUT A SETTING AND THAT'S WHAT THEY'D DONE THE FIRST DAY BUT ON THE SECOND DAY SOMEONE CALLED THEM TO REVIEW INFORMATION (PATIENT DIDN'T KNOW WHO AND PATIENT SERVICES ASKED IF IT WAS SUPPORT LINK AND THE PATIENT STATED 'MAYBE') AND TOLD THE PATIENT NOT TO TOUCH ANYTHING SO THE PATIENT STATED THEY LEFT THE SETTINGS ALONE AFTER THAT. THE PATIENT STATED THE SUPPOSED SUPPORT LINK AGENT ASKED ABOUT THEIR SYMPTOMS AND THE PATIENT STATED THEY THOUGHT THEY TOLD THE AGENT ALL WRONG ABOUT THEIR BLADDER AND BOWEL SYMPTOMS BECAUSE THEY HAD BEEN CONFUSED ABOUT WHAT TO REPORT. PATIENT SERVICES REVIEWED TRIAL AND THERAPY EXPECTATIONS WITH THE PATIENT AS WELL AS DEVICE DESCRIPTION/FUNCTION. THE PATIENT STATED THEY WERE TOLD BY THE HEALTH CARE PROVIDER (HCP) TO CHANGE THE DRESSING LAST NIGHT (2023-NOV-09) SO LAST NIGHT THEIR SPOUSE HELPED THEM CHANGE IT BUT THE SPOUSE THOUGHT THEY MEANT T

  Patient problems: Insufficient Information; Numbness; Undesired Nerve Stimulation

  MAUDE report 18132099 ↗
• InjuryNov 6, 2023Adverse 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 FECAL INCONTINENCE AND URGE INCONTINENCE. THEIR TRIAL START DATE WAS (B)(6) 2023. IT WAS REPORTED THAT THEY HAD A DEVICE SITE INFECTION. THEY WERE HOSPITALIZED AND REQUIRED ANTIBIOTICS. IT IS UNKNOWN IF THE ISSUE WAS RESOLVED. ON 2023-NOV-02, THEY REPORTED THAT THEY WOULD BE SEEING THEIR HEALTHCARE PROVIDER (HCP) TOMORROW WHERE THEY WILL REMOVE THE ENS BECAUSE OF THE INFECTION AND WILL TRY AGAIN ONCE THEY ARE HEALED. THEY WERE REDIRECTED TO THEIR HCP.

  Patient problems: Unspecified Infection

  MAUDE report 18074728 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Data Problem; Adverse Event Without Identified Device or Use Problem; Data Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR BOWEL ISSUES. IT WAS REPORTED THAT THEIR TRIAL BEGAN ON WEDNESDAY (B)(6) 2023 AND THAT THEY WERE SUPPOSED TO HAVE IT FOR A WEEK BUT THEY MIGHT ALSO DO IT FOR TWO WEEKS BECAUSE OF THEIR UNIQUE SITUATION: THE PATIENT STATED THEY DIDN'T HAVE A COLON SO THEIR SMALL INTESTINE WAS ATTACHED TO THEIR ANUS WHICH MADE THEM SUSCEPTIBLE TO GETTING DEHYDRATED/THEY WERE ALWAYS DEHYDRATED AND THEY WERE ALWAYS HORRIBLY SENSITIVE TO THE ANESTHESIA. THE PATIENT STATED THE PAIN MEDS FROM THE ANESTHESIA AT THEIR TRIAL PROCEDURE SHUT THEIR BOWELS DOWN. SO THEY KNEW IT WASN'T WORKING AS WELL AS IT COULD HAVE FOR THEIR SYMPTOMS FOR THE FIRST TWO DAYS BECAUSE THEY HAD BEEN REALLY CONSTIPATED. THE PATIENT STATED FOR THEIR CONDITION THEY COULDN'T HAVE FIRM STOOLS, THEY NEEDED TO HAVE WATERY/DIARRHEA TYPE STOOLS. THE PATIENT STATED THEY WERE GROGGY INITIALLY IN THE HOSPITAL SO THEY DIDN'T REMEMBER WHAT THEY WERE TOLD FOR TRACKING THEIR SYMPTOMS AND THAT THE SETTING MUST HAVE BEEN ACCIDENTLY CHANGED WHILE THEY HAD THE THERAPY SETTINGS PULLED UP BY GETTING "BUMPED" OR SOMETHING WHILE IT WAS ON THEIR HOSPITAL BED S

  Patient problems: Erythema; Fluid Discharge; Insufficient Information; Itching Sensation; Rash; Unspecified Infection

  MAUDE report 18048267 ↗
• InjuryOct 18, 2023Adverse 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 NON-OBSTRUCTIVE URINARY RETENTION, FECAL INCONTINENCE. THE TRIAL STARTED ON (B)(6) 2023. IT WAS REPORTED THAT PATIENT HAD WORSENING BASELINE URINARY RETENTION. THEY HAD A NEW SYMPTOM OF BOWELS BEING RUNNY LIKE DIARRHEA. ON AN ADDITIONAL CALL PATIENT REPORTED THEY ARE STILL NOT FEELING THE URGE TO URINATE AND THEY ARE HAVING BOUTS OF WATERY DIARRHEA. PATIENT SAID THEY WERE TOLD TO "PLAY WITH IT" AND SEE WHERE THEY FEEL COMFORTABLE BUT WEREN'T SURE WHAT KIND OF ADJUSTMENTS SHOULD BE MADE. PATIENT ALSO MENTIONED THAT SINCE IMPLANT, THEY FEEL LIKE THERE'S A BUMP ON HE LEFT SIDE WHERE THEY HAVE A GAUZE PAD. PATIENT SAID IT'S ALSO ITCHY. REVIEWED GENERAL THERAPY GUIDELINES, THERAPY OPTIMIZATION AND EXPECTATIONS AND STIMULATION SENSATION. PATIENT INCREASED STIM ON THE CALL TO A COMFORTABLE LEVEL. PATIENT SAID HCP TOLD THEM TO WAIT 24 HOURS IN BETWEEN ADJUSTMENTS. PATIENT WILL MONITOR SYMPTOMS. REDIRECTED PATIENT TO HCP ABOUT BUMP AND ITCHINESS MENTIONED. PATIENT MENTIONED THEY ARE UNDERGOING THE ADVANCED (2 WEEK) TRIAL. THE ISSUE WAS ONGOING.

  Patient problems: Diarrhea; Insufficient Information; Urinary Retention

  MAUDE report 17959940 ↗
• InjuryOct 18, 2023Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Failure to Deliver Energy; Failure to Interrogate; Communication or Transmission 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. THE REASON FOR CALL WAS SINCE YESTERDAY, PATIENT HAS NOTICED THAT THEIR ENS IS TURNING THERAPY OFF ON ITS OWN. PATIENT WAS SHOWN HOW TO TURN THERAPY BACK ON AND NOTICES THAT THEY ARE ABLE TO VOID WHEN THE THERAPY IS ON. WHEN THE THERAPY IS OFF, THEY NOTICED THAT THEY ARE NOT ABLE TO VOID, SO THEY CONNECT TO THEIR ENS AND SEE THE THERAPY HAS TURNED OFF. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO CHECK ENS IN PERSON. OFFERED TO REACH OUT TO MANUFACTURING REPS TO SEE IF THEY MAY BE ABLE TO HELP IN PERSON. EMAIL SENT TO FIELD STAFF.

  Patient problems: Pain; Urinary Retention

  MAUDE report 17954665 ↗
• MalfunctionOct 9, 2023Energy Output Problem; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR NON-OBSTRUCTIVE URINARY RETENTION. THEIR TRIAL START DATE WAS (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT/SORENESS/PINCHING. IT IS UNKNOWN IF THE ISSUE WAS RESOLVED. THE PATIENT REPORTED THEY WERE STILL SORE FROM THE PROCEDURE YESTERDAY ((B)(6) 2023) BUT THEY WERE CALLING TO INQUIRE ABOUT THE STIMULATION SENSATION. THE PATIENT WANTED TO KNOW IF THE STIMULATION SHOULD STAY IN THE SAME PLACE OR NOT BECAUSE THE STIMULATION FELT LIKE IT WAS "ROTATING" FOR THEM BETWEEN THEIR PENIS, GROIN AND LOWER BUTTOCKS. THE PATIENT FURTHER EXPLAINED THAT DURING THE PROCEDURE WHEN THEY WERE LAYING ON THEIR STOMACH, THEY FELT THE STIMULATION IN THEIR PENIS AREA AND GROIN AREA BUT WHEN THEY WERE STANDING IT FELT MORE TOWARDS THE BUTTOCKS AND WHEN THEY WERE SITTING IT FELT LIKE IT WAS LOWER. PATIENT SERVICES REVIEWED STIMULATION CONSIDERATIONS AND THERAPY EXPECTATIONS WITH THE PATIENT. THE PATIENT CONFIRMED THE STIMULATION WAS COMFORTABLE FOR THEM AND STATED THE THERAPY WAS DEFINITELY HELPING THEIR SYMPTOMS OF CHRONIC URINARY RETENTION BY MORE THAN 50% REDUCTION. THE PATIENT ST

  Patient problems: Discomfort

  MAUDE report 17894121 ↗
• MalfunctionOct 6, 2023Display or Visual Feedback Problem; Failure to Interrogate; Migration or Expulsion of Device; Energy Output Problem; Communication or Transmission Problem; Display or Visual Feedback Problem; Failure to Interrogate; Migration or Expulsion of Device; Energy Output Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT'S HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THAT THE COMMUNICATION ERROR WAS CLARIFIED TO MEAN THEY WERE UNABLE TO COMMUNICATE. THE CAUSE OF THIS ISSUE WAS UNKNOWN. THE HCP DIDN'T HAVE TO DO ANYTHING AS IT WAS ABLE TO RECONNECT WITH THE DEVICE. THE ISSUE WAS RESOLVED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Micturition Urgency; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886045 ↗
• MalfunctionSep 15, 2023Failure to Deliver Energy; Migration or Expulsion of Device; Energy Output Problem; Therapy Delivered to Incorrect Body Area; Insufficient Device Problem Information; Failure to Deliver Energy; Migration or Expulsion of Device; Energy Output Problem; Therapy Delivered to Incorrect Body Area; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT TO CLARIFY THE DEVICE NOT WORKING, THE PATIENT DID NOT UNDERSTAND THE EXPECTED SENSATION OR HOW TO WORK THE DEVICE WELL. NOTHING WAS WRONG/DEFECTIVE WITH THE DEVICE. THE CAUSE OF THE DEVICE NOT WORKING WAS USER ERROR AS THE PATIENT WAS DIFFICULT TO EDUCATE. THE ISSUE HAS BEEN RESOLVED. THE CAUSE OF THE PATIENT NOT FEELING STIMULATION IN THE BIKE SEAT AREA WAS DETERMINED. THE PATIENT HAS CONCURRENT BACK PAIN AND HAD DISCOMFORT NEAR THE BANDAID. THE ISSUE HAS BEEN RESOLVED.

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

  MAUDE report 17760962 ↗
• MalfunctionAug 8, 2023Migration or Expulsion of Device; Application Program Problem; Migration or Expulsion of Device; Application Program Problem

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. IT WAS NOTED THE PATIENT'S TRIAL STARTED ON (B)(6) 2023. IT WAS REPORTED THAT THE PATIENT'S DEVICE REACHED A MAX SETTING OF 4.2 ON THE RIGHT SIDE. THE ISSUE IS ONGOING. (B)(6) PATIENT MENTIONED FEELING A LITTLE SORE AND A BURNING LIKE SENSATION. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE CAUSE WAS MOST LIKELY DETERMINED TO BE THAT THE TEMPORARY LEAD MOVED AWAY FROM THE NERVE.

  Patient problems: Burning Sensation; Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17483780 ↗
• MalfunctionAug 2, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE. THEIR TRIAL START DATE WAS (B)(6) 2023. IT WAS REPORTED THAT THE LEAD BROKE OFF. THE CAUSE WAS UNKNOWN. IT IS UNKNOWN IF THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17444425 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM AN UNKNOWN SOURCE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT  THE PATIENT HAD AN INTESTINAL INFECTION WITH VOMITING AND FEVER OCCURRING BETWEEN THE LEAD IMPLANT AND FOLLOW-UP. SYMPTOMS INCLUDE ACUTE COLITIS, DIARRHEA, DEHYDRATION, AND HYPERLIPIDEMIA. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2023 AND CAME OUT ON (B)(6) 2023. IT WAS STARTED THAT THIS WAS NOT RELATED TO THE DEVICE OR THERAPY BUT WAS RELATED TO THE STUDY PROCEDURE. THE PATIENT WAS PRESCRIBED THE FOLLOWING: LOPERIMIDE 2MG TID METRONIDAZOLE 500MG Q12H.

  Patient problems: Dehydration; Diarrhea; Fever; Inflammation; Insufficient Information; Unspecified Infection; Vomiting

  MAUDE report 17386049 ↗
• MalfunctionJul 18, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URGE INCONTINENCE. IT WAS NOTED THAT THE PATIENTS TRIAL STARTED ON (B)(6) 2023. IT WAS REPORTED THAT LEAD BROKE IN HALF WHEN SLEEPING. ONE LEAD SEPARATED FROM ENS EXTENSION, OTHER ONE BROKE AT THE CONNECTOR TIP. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE HCP REPORTED THAT THE WIRE CAME OUT OF WHITE CONNECTION. THEY RESTATED IT HAPPENED WHILE SLEEPING. THEY HAD PATIENT PULL THE WIRE OUT. THE ISSUE HAD BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17346950 ↗
• MalfunctionJul 5, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  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 PATIENT'S TRIAL STARTED ON (B)(6) 2023. IT WAS REPORTED THAT THERE IS A LEAD ISSUE OF MIGRATION, LEAD MOVED OR WIRE MOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262230 ↗
• MalfunctionJun 8, 2023Failure to Interrogate; Migration or Expulsion of Device; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Interrogate; Migration or Expulsion of Device; Communication or Transmission Problem; Insufficient Device Problem Information

  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) 2023. IT WAS REPORTED THAT THEY HAD A SUSPICION THAT SOMETHING CHANGED WITH THE STIMULATOR AND WHEN THEY TRIED TO ADJUST STIMULATION TO SEE IF THEY FELT CHANGES THE PATIENT (PT) REPORTED GETTING AN ERROR MESSAGE. THE PT INITIALLY REPORTED ON THE CALL GETTING UNABLE TO COMMUNICATE WITH DEVICE MESSAGE (COMMUNICATION LOST, ENSURE ENS IS IN RANGE AND BATTERIES ARE IN PLACE). THE PT CONTINUED GETTING THIS MESSAGE DESPITE PRESSING RETRY AND CONFIRMED HANDSET WAS NEAR ENS. WITH ASSISTANCE THE PT HAD ENS DISCOVERY BUTTON PRESSED AND HELD AND STATED LED LIGHT STARTED FLASHING. FOLLOWING THIS THE PT REPORTED GETTING MESSAGE THAT THE DEVICE (B)(6) IS NOT SETUP PROPERLY FOR PT USE. THE PT STATED WHEN THEY FIRST SET UP THEIR DEVICE ON FRIDAY THEY SHOWED THE PT HOW TO WORK EXTERNAL DEVICES, BUT THE PT NEVER DID ANYTHING WITH IT BECAUSE THEY WERE TOLD THEY SHOULD NOT NEED TO. THE PT REPORTED THEY THINK THEY MESSED SOMETHING UP WITH IT WHEN THEY CHANGED THEIR BANDAGE TODAY AND THAT'S WHEN THEY TRIED TO CONNECT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17089876 ↗
• MalfunctionMay 2, 2023Break; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Break; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (TRIAL PATIENT, MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING NEW SYMPTOMS OF CONSTIPATION AND DYSURIA. IT IS UNKNOWN IF THE ISSUE WAS RESOLVED. ON (B)(6) 2023, THE PATIENT REPORTED THAT THEIR LEAD BECAME UNPLUGGED. THE LEADS HAD BEEN PULLED FROM THEIR BACK AND WERE BROKEN/DISCONNECTED. THE PATIENT COULDN'T EXPLAIN HOW THE CORDS WERE AND DIDN'T SEE WHERE ANYTHING WOULD PLUG IN. THEY STATED THAT "IT'S LIKE ITS BROKEN IN HALF. IT'S JUST HANGING HERE AND SITTING IN MY HANDS".  THE PATIENT CALLED SUPPORT LINK AND MADE THEM AWARE THAT THE PERC EXTENSION WAS "BROKEN IN HALF", AND ALSO CALLED THE HEALTHCARE PROVIDER 'S (HCP) OFFICE AND THE MANUFACTURER REPRESENTATIVE (REP) REGARDING THE BROKEN LEAD. THE PATIENT STATED THAT THEY HADN'T HEARD BACK FROM THE REP OR THE HCP ABOUT THEIR DEVICE BEING BROKEN AT THE TIME. THE REP REPORTED THAT THE DOCTOR THEN ADVISED THE PATIENT TO PUT THE ENS AND BROKEN EXTENSION AND REMOTE IN A BOX AND BRING IT TO THEIR SCHEDULED STAGE 2 ON (B)(6) 2023. STAGE 2 WAS S

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

  MAUDE report 16853600 ↗
• InjuryApr 27, 2023Failure to Interrogate; Migration or Expulsion of Device; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem; Failure to Interrogate; Migration or Expulsion of Device; Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE ISSUE WAS RESOLVED AND THE RETRIAL WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823132 ↗

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