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Verify™ 353101 (UDI 00763000879273)Recalls & reported problems

Medtronic, Inc. · ENS 353101 VERIFY ISTM US EMANUAL · Class 3

Adverse event reports
15
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000879273), received between Oct 22, 2024 and Mar 12, 2026 — classified as 6 injuries, 9 malfunctions.

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

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 2 reportsMar 2025: 0 reportsApr 2025: 2 reportsMay 2025: 1 reportsJun 2025: 1 reportsJul 2025: 1 reportsAug 2025: 2 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Migration or Expulsion of Device7
  • Adverse Event Without Identified Device or Use Problem4
  • Disconnection3
  • Failure to Deliver Energy3
  • Communication or Transmission Problem1
  • Failure to Interrogate1
  • High impedance1
  • Material Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions11
  • Insufficient Information4
  • Calcium Deposits/Calcification1
  • Cramp(s) /Muscle Spasm(s)1
  • Hemorrhage/Blood Loss/Bleeding1
  • Micturition Urgency1
  • Pain1
  • Sleep Dysfunction1

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 12, 2026Material Twisted/Bent

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. THEIR TRIAL STARTED ON (B)(6) 2026. IT WAS REPORTED THAT THE LEAD STYLET APPEARED TO BE DAMAGED WHEN PHYSICIAN PULLED THE LEAD OUT OF THE PROTECTIVE COVER AND ATTEMPTED TO INSERT INTO THE PATIENT. THE LEAD STYLET WAS SLIGHTLY PULLED OUT FROM THE LEAD AND WAS NOTICED THAT IT WAS BENT AT THE DISTAL PART OF THE STYLET. THEREFORE, THE LEAD COULD NOT BE USED AND AN EXTRA LEAD HAD TO BE UNPACKED. ANOTHER THING TO NOTICE WAS THAT IT WAS UNCLEAR WHICH LEAD WAS DAMAGED- UNSURE IF IT WAS THE LEAD THAT IS INCLUDED IN THE 309201 KIT WITH LOT #60694174 OR THE STAND ALONE LEAD WITH LOT #60676799 AS THEY WERE ALREADY PLACED DOWN IN THE SURGICAL FIELD DURING THE PROCEDURE. THE CAUSE OF THE ISSUE WAS UNKNOWN. IT WAS UNKNOWN WHETHER THE ISSUE WAS RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24578039 ↗
  • InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. WHEN ASKED TO CLARIFY THE STATEMENT, THEY REPORTED THAT THEY HAD BEEN FEELING LIKE THEY HAD TO PEE, BUT WHEN THEY GO TO THE BATHROOM, THEY DIDN'T NEED TO PEE AND IF THEY EXPERIENCED URINARY RETENTION, THEY STATED THAT THEY USED TO BUT NOT ANYMORE. THE PATIENT DID NOT EXPERIENCE URINARY RETENTION PRIOR TO THE DEVICE AND THE RETENTION DID NOT WORSEN AS A RESULT OF THE DEVICE OR THERAPY. IT WAS UNKNOWN IF CATHETERIZATION AS THE 'STANDARD OF CARE' PRIOR TO THE DEVICE. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED. THE DEVICE WAS INTENDED TO TREAT URGENCY FREQUENCY.

    Patient problems: Cramp(s) /Muscle Spasm(s); Micturition Urgency; Urinary Retention

    MAUDE report 23743436 ↗
  • MalfunctionSep 4, 2025Failure to Deliver Energy; Migration or Expulsion of Device; Failure to Deliver Energy; Migration or Expulsion of Device

    ON (B)(6) 2025, INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY AND OR FREQUENCY). IT WAS UNKNOWN WHEN THE TRIAL WAS INITIATED. IT WAS REPORTED THAT THE THERAPY WAS TURNED OFF. TROUBLESHOOTING WAS PERFORMED AS THE PATIENT RELAUNCHED THE APP AND TURNED ON THE THERAPY AND SET THE STIM TO THE LEVEL WHERE IT WAS BEFORE IT WAS TURNED OFF. THE CAUSE WAS NOT KNOWN. THE ISSUE WAS RESOLVED. TODAY, PATIENT REPORTED THAT THE THERAPY WAS TURNED OFF 45MIN AGO. ON 2025-AUG-27, ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP). THEIR TRIAL STARTED ON (B)(6) 2025. THE CAUSE OF THE THERAPY BEING TURNED OFF WAS NOT DETERMINED. THE MOST LIKELY CAUSE/CONTRIBUTION TO THE ISSUE WAS NOTED TO BE THE PERIPHERAL NERVE EVALUATION (PNE) LEAD BEING TUGGED OR INADEQUATE GROUNDING. THE ISSUE OCCURRED ON THE LAST DAY OF THE TRIAL.

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

    MAUDE report 22960635 ↗
  • MalfunctionAug 27, 2025High impedance; High impedance

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DISFUNCTION. IT WAS REPORTED THAT THE REP CALLED TODAY IN A CASE REPORTING THEY SAW HIGH IMPEDANCES ON THE LEAD WITH THE ENS ON ONE CONTACT, IN CONNECTING TO INS THEY THEN SAW ALL 4 CONTACTS HAVE HIGH IMPEDANCES. THE AGENT ASKED ABOUT CHECKING WITH THE ENS AGAIN BUT THEY WERE WITH THE INS. ASKED IF THEY HAD SET UP A PROGRAM TO RUN FOR A FEW MINUTES TO CHECK BELLOWS/TOES. THE REP REPORTED THAT THE PATIENT WAS NOT SEEING ANY MOTOR RESPONSES DUE TO UNDERLYING ISSUES. THE SYSTEM WAS ONLY LETTING THEM GO UP 1.2 MA AND NOTHING FURTHER. THE AGENT ASKED TO CHECK THE INS SET SCREW, MAKE SURE LEAD WAS SNUG AFTER TIGHTENING WHICH CALLER STATED THEY DID. THE AGENT REVIEWED TRYING A NEW INS, IF RESULTS DO NOT CHANGE, THEN CONSIDER LEAD REPLACEMENT. IN AN EMAIL RESPONSE THE REP INDICATED THAT THE FIRST TIME, IMPEDANCE FAILED ON 0 AND 1. THEY RE-RAN IMPEDANCE A SECOND TIME AND IT FAILED ON ALL FOUR ELECTRODES. AFTER SPEAKING WITH IT, THE REP WAS DIRECTED TO CHANGE OUT THE INS, WHICH THEY DID. IMPEDANCE STILL FAILED. THEY SWITCHED OUT T

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22909026 ↗
  • MalfunctionAug 7, 2025Migration 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 THE MANUFACTURING REPRESENTATIVE (REP). THEY REPORTED THAT THE LEADS DID NOT MOVE, THE PATIENT JUST FELT SENSORY DIFFERENTLY. THE ISSUE WAS RESOLVED. THEY DID NOT ASK THE CUSTOMER TO RETURN THE DEVICE.

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

    MAUDE report 22735274 ↗
  • InjuryJul 18, 2025Disconnection; Disconnection

    INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT USING AN EXTERNAL NEUROSTIMULATOR (ENS). IT WAS REPORTED THAT THEY JUST FINISHED WITH A STAGE 1 IMPLANT AND WERE RECEIVING MESSAGE ON HANDSET, "NO LEADS ATTACHED TO CABLE, ENSURE ALL CONNECTIONS ARE SECURE". CALLER STATED THAT THEY'VE ALREADY TAPPED RETRY, REPLACED BOTH THE HANDSET AND ENS AND MESSAGE WAS STILL COMING UP. CALLER STATED LEAD APPEARED TO BE FUNCTIONING AS INTENDED IN THE OR. THE CALLER WAS NOT WITH THE PATIENT. TECHNICAL SERVICES (TSS) SUGGESTED ENSURING THE ALL CONNECTIONS ARE SECURE WITH PERC EXTENSION AND IF SO, LIKELY THE PERCUTANEOUS EXTENSION WILL NEED TO BE REPLACED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE REP STATED THAT THE CAUSE OF THE NO LEADS ATTACHED TO CABLE ERROR MESSAGE WAS DETERMINED. WHEN ASKED ABOUT THE MOST LIKELY CAUSE OF THE EVENT, THE REP STATED THAT THE LEAD WAS NOT FULLY INSERTED INTO THE PERCUTANEOUS EXTENSION. WHEN ASKED ABOUT THE STEPS TAKEN TO RESOLVE THE ISSUE, THE REP STATED THAT THE POCKET SITE WAS OPENED AND THE LEAD REINSERTED INTO THE PERCUTANEOUS EXTENSION AND TESTED. THE REP STATED THAT THE ISSU

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22539488 ↗
  • InjuryJun 18, 2025Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

    INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URINARY/BOWEL DYSFUNCTION/SACRAL NERVE STIM AND FECAL INCONTINENCE. IT WAS REPORTED THAT DURING THE TRIAL THE LEAD SLIPPED. ON 2025-JUN-16 ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) AND THE MANUFACTURING REPRESENTATIVE (REP) . THE HCP REPORTED THAT ON (B)(6) 2024 THE PATIENT HAD THEIR PROCEDURE WITH THEIR TRIAL AND EVERYTHING WAS SUCCESSFUL. ON (B)(6) 2025 THE PATIENT COMPLAINED OF ABNORMAL SENSATIONS FROM THE DEVICE. FLUOROSCOPY CONFIRMED THAT THEIR PRE-EXISTING STAGE 1 LEAD HAD SOMEHOW SHIFTED INTO AN ABNORMAL POSITION WHERE IT HAD CURLED ON ITSELF. THE DOCTOR THEREFORE PLACED A NEW LEAD ON THE LEFT SIDE AT THE S3 LEVEL AND TESTED THIS NEW LOCATION WHICH SEEMED BETTER THAN HER PREVIOUS LEAD. SO, THIS LEAD WAS REMOVED AND A NEW ONE WAS PLACED FOR THE PERMANENT IMPLANT. THE NEW IMPLANT PROCEDURE WAS DONE SUCCESSFULLY WITH NO ISSUES.

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

    MAUDE report 22281219 ↗
  • InjuryMay 22, 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 UNKNOWN WHEN THE TRIAL STARTED. IT WAS REPORTED THAT THEY HAD AN INFECTION WHERE THEY INSERTED THE WIRES. IT WAS UNKNOWN WHETHER THE ISSUE WAS RESOLVED.

    Patient problems: Calcium Deposits/Calcification; Unspecified Infection; Unspecified Tissue Injury

    MAUDE report 22069896 ↗
  • MalfunctionApr 23, 2025Migration 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

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

    Patient problems: No Clinical Signs, Symptoms or Conditions; Pain; Urinary Frequency / Polyuria

    MAUDE report 21887807 ↗
  • MalfunctionApr 17, 2025Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

    INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR URINARY/BOWEL DYSFUNCTION AND URGE INCONTINENCE AND FECAL INCONTINENCE. IT WAS NOTED THAT THE PATIENT'S TRIAL STARTED ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING COMMUNICATION ISSUES. MESSAGE WAS "SYSTEM ERROR, THERAPY MAY HAVE STOPPED. PLEASE CONTACT YOUR CLINICIAN." REMOVED AND REPLACED BATTERIES WITH THE ISSUE RESOLVING AND NOT OCCURRING AGAIN. CAUSE WAS STATED TO BE THE HANDSET. IT WAS REPORTED THAT THE ISSUE WAS RESOLVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21858806 ↗
  • InjuryFeb 3, 2025Disconnection; Disconnection

    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 REP CALLED FROM RECOVERY AFTER JUST FINISHING A STAGE 1 TRIAL IMPLANT. CALLER REPORTED GETTING MESSAGE ON THEIR CLINICIAN APP SAYING, "[SERIAL NUMBER] CONNECTION ERROR. NO LEAD ATTACHED TO CABLE. MAKE SURE ALL CONNECTIONS ARE SECURE AND TAP RETRY." CALLER STATED THEY UNPLUGGED AND REPLUGGED THE CABLE AS WELL AS TAKING THE ENS BATTERIES OUT AND REPLACING THEM, BUT WAS STILL GETTING THE SAME MESSAGE. CALLER SAID THAT WITH EACH ATTEMPT THEY WERE COMPLETELY CLOSING OUT OF THE APP. WHILE ON THE CALL, CALLER TRIED REPLACING THE ENS AND TURNING CLINICIAN PROGRAMMER COMPLETELY OFF FOR AT LEAST 1 MINUTE BEFORE TURNING BACK ON, BUT NO SUCCESS WITH EITHER. CALLER SAID THEY WERE PREPPING THE OR TO GO BACK IN TO CHECK THE CONNECTION OF THE LEAD TO EXTENSION ONCE MORE. AGENT REVIEWED AT THIS POINT THAT WAS LIKELY THE CAUSE OF THE MESSAGE. CALLER DID STATE THAT DURING THE PROCEDURE THEY VISUALIZED THE LEAD BEING INSERTED COMPLETELY INTO THE EXTENSION. THIS TIME, CALLER SAID THEY WOULD HAVE SURGEON DO A GENTLE TU

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21294108 ↗
  • InjuryFeb 3, 2025Disconnection; Disconnection

    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 REP CALLED FROM RECOVERY AFTER JUST FINISHING A STAGE 1 TRIAL IMPLANT. CALLER REPORTED GETTING MESSAGE ON THEIR CLINICIAN APP SAYING, " [SERIAL NUMBER] CONNECTION ERROR. NO LEAD ATTACHED TO CABLE. MAKE SURE ALL CONNECTIONS ARE SECURE AND TAP RETRY." CALLER STATED THEY UNPLUGGED AND REPLUGGED THE CABLE AS WELL AS TAKING THE ENS BATTERIES OUT AND REPLACING THEM, BUT WAS STILL GETTING THE SAME MESSAGE. CALLER SAID THAT WITH EACH ATTEMPT THEY WERE COMPLETELY CLOSING OUT OF THE APP. WHILE ON THE CALL, CALLER TRIED REPLACING THE ENS AND TURNING CLINICIAN PROGRAMMER COMPLETELY OFF FOR AT LEAST 1 MINUTE BEFORE TURNING BACK ON, BUT NO SUCCESS WITH EITHER. CALLER SAID THEY WERE PREPPING THE OR TO GO BACK IN TO CHECK THE CONNECTION OF THE LEAD TO EXTENSION ONCE MORE. AGENT REVIEWED AT THIS POINT THAT WAS LIKELY THE CAUSE OF THE MESSAGE. CALLER DID STATE THAT DURING THE PROCEDURE THEY VISUALIZED THE LEAD BEING INSERTED COMPLETELY INTO THE EXTENSION. THIS TIME, CALLER SAID THEY WOULD HAVE SURGEON DO A GENTLE T

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21293618 ↗
  • MalfunctionJan 20, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP). THE HCP REPORTED THAT THE LEAD WAS IMPLANTED ON (B)(6) 2025. THE STEPS TAKEN TO RESOLVE THE ISSUE WAS THAT THE PATIENT FELL AT HOME AND FRACTURED FEMUR AND THE WIRES WERE REMOVED IN A TIMELY MANNER INPUT. THE DEVICE WAS INTENDED TO TREAT NON-OBSTRUCTIVE URINARY RETENTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21194263 ↗
  • MalfunctionNov 25, 2024Failure to Deliver Energy; Migration or Expulsion of Device; Patient Device Interaction Problem; Failure to Deliver Energy; Migration or Expulsion of Device; Patient Device Interaction Problem

    INFORMATION WAS RECEIVED FROM A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR FECAL INCONTINENCE. THE TRIAL BEGAN ON (B)(6) 2024. IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING LOSS OF STIMULATION AND THE PATIENT REACHED MAX SETTINGS. TROUBLESHOOTING PERFORMED WAS UNKNOWN. THE ISSUE RESOLVED WAS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL (HCP). THEY REPORTED THAT THE CAUSE OF THE MAX SETTING WAS DETERMINED TO BE UNKNOWN. THEY MENTIONED MOST LIKELY LEAD MOVED AWAY FROM NERVE FROM NORMAL ACTIVITIES AND DAILY LIVING. TO RESOLVE THE ISSUE, THEY ATTEMPTED SWITCHING SIDES WHERE MAX SETTING WERE REACHED AS WELL AS LEFT IT AT MAX SETTING ON (B)(6) 2024. THE ISSUE WAS NOT RESOLVED AND NO FURTHER ACTION WILL BE TAKEN. TO RESOLVE THE LOSS OF STIMULATION WAS INCREASED ON (B)(6) 2024. THE ISSUE WAS NOT RESOLVED AND NO FURTHER ACTION WILL BE TAKEN.

    Patient problems: Insufficient Information

    MAUDE report 20769668 ↗
  • MalfunctionOct 22, 2024Failure to Deliver Energy; Migration or Expulsion of Device; Failure to Deliver Energy; Migration or Expulsion of Device

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL(HCP). WHEN ASKED THE STEPS TAKEN TO RESOLVE THE PULLING OF THE LEAD, THE HCP REPORTED THAT THEY HAD A PHONE CALL WITH THE PATIENT ON THAT ON (B)(6) 2024 AND THE MANUFACTURING REPRESENTATIVE(REP) WAS AWARE AS SOON AS POSSIBLE (SAME DAY). THE ISSUE WAS RESOLVED. THE CAUSE OF THE THERAPY/SETTING BEING OFF WAS NOT DETERMINED. AS PER THE REP, THE CAUSE OR CONTRIBUTED TO THE ISSUE WAS THAT THE PROGRAMMER WAS STILL CONNECTED AND THERAPY WAS WORKING. THE ISSUE WAS RESOLVED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding; Sleep Dysfunction

    MAUDE report 20503126 ↗

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

Other Stimulator, electrical, implantable, for incontinence devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.