Verify™ 3531 (UDI 00643169567764)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169567764), received between Dec 14, 2016 and Sep 13, 2017 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2017Failure to Interrogate; Battery Problem; Communication or Transmission Problem; Device Operates Differently Than Expected; Failure to Interrogate; Battery Problem; Communication or Transmission Problem; Device Operates Differently Than Expected

  PATIENT HAD A PROBLEM LAST NIGHT. PATIENT STATED AFTER DRIVING YESTERDAY, THEY WERE UNSURE HOW, BUT HIS DEVICE STOPPED WORKING. UPON FURTHER INSPECTION, THEY REALIZED THE ENS BATTERIES WERE DEAD. PATIENT HAD ALREADY BOUGHT THE BATTERIES TO REPLACE THEM, BUT WAITED TO SPEAK WITH SOMEONE FIRST. THEY CONFIRMED AGAIN IT WAS INDEED THE ENS THAT HAD DEAD BATTERIES. PATIENT HAD NEW BATTERIES BUT HAD NOT REPLACED THEM YET. PATIENT STATED THE FIRST DAY OF EVALUATION, THEY SAW IMPROVEMENT AND WAS ABLE TO VOID ON THEIR OWN BUT SINCE ENS HAD BEEN DEAD, THEY HAD NOT BEEN ABLE TO VOID ON THEIR OWN. PATIENT DID NOT REALLY GET AN URGENCY TO VOID, THEY JUST GOT PAIN IN THEIR KIDNEYS WHICH LET THEM KNOW THAT THEY HAD TO GO. PREMATURE BATTERY DEPLETION, UNABLE TO REMAIN SYNCED TO REMOTE OR TESTING CABLE. BATTERIES CHANGED IN BOTH ENS AND REMOTE AND RE SYNCED BY TECHNICAL SERVICES, UNSUCCESSFUL. THEY TRIED TO SYNC A NEW REMOTE TO THE ENS IN THE OFFICE AND WAS UNABLE TO GET IT TO STAY ACTIVE. THEY THEN REPLACED THE ENS WITH A NEW ONE AND IT WORKED FINE. PATIENT WAS ADVISED TO CONSULT WITH DOCTOR FOR MORE INFORMATION. THERE WERE NO COMPLICATIONS OR THAT NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Pain; Therapeutic Response, Decreased; Urinary Retention

  MAUDE report 6861255 ↗
• MalfunctionApr 20, 2017Migration or Expulsion of Device; Unintended Collision; Migration or Expulsion of Device; Unintended Collision

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS) FOR TRIAL STIMULATION WHO REPORTED THAT THE PATIENT HAD A CHANGE IN SENSATION AND LEG PAIN AFTER BEING IN A CAR ACCIDENT DURING THEIR BASIC EVALUATION. THE CALLER INDICATED THAT THE PATIENT WAS REAR-ENDED BY ANOTHER VEHICLE AND HAD THEIR ENS TURNED OFF WHILE IN THE EMERGENCY ROOM, BUT THEN TURNED IT BACK ON AFTER DISCHARGE FROM THE ER. WHEN THE PATIENT ARRIVED AT THE HOSPITAL FOR THEIR STAGE TWO PROCEDURE THEIR HEALTHCARE PROVIDER (HCP) TESTED THE TRIAL LEAD AND FOUND THAT "AMPLITUDE LEVELS" WERE HIGHER THAN WHEN THE INITIAL LEAD WAS PLACED. THE HCP THEN CONFIRMED THAT THE LEAD HAD MIGRATED DEEPER, THE HCP REMOVED THE PREVIOUS TRIAL LEAD AND PLACED THE STAGE TWO LEAD WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). THE LEAD ISSUE WAS NOTED AS RESOLVED AT THE TIME OF THIS REPORT AND A MANUFACTURER REPRESENTATIVE (REP) NOTED THAT THE STAGE TWO LEAD/SYSTEM PROVIDED BELLOWS AND TOE RESPONSE ON ALL ELECTRODES. THERE WERE NO FURTHER COMPLICATION REPORTED OR ANTICIPATED.

  Patient problems: Pain; Therapeutic Effects, Unexpected

  MAUDE report 6507122 ↗
• MalfunctionFeb 16, 2017Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Malposition of Device; Device Operates Differently Than Expected; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Malposition of Device; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. THE REPRESENTATIVE REPORTED THAT THE SHOCKING IN THE LEFT BUTTOCKS WAS CAUSED BY THE LEFT LEAD BEING TOO CLOSE TO A NERVE. WHEN THEY CHANGED THE ENS OUT FOR A DIFFERENT, THE SYMPTOMS REMAINED THE SAME. AS AN INTERVENTION, THE ENS WAS PROGRAMMED SO THAT THE STIMULATION WAS ONLY DELIVERED TO THE RIGHT SIDE LEAD DURING THE BASIC EVALUATION.

  Patient problems: Electric Shock; Therapeutic Effects, Unexpected; Undesired Nerve Stimulation

  MAUDE report 6337755 ↗
• MalfunctionFeb 10, 2017Break; Failure to Deliver Energy; Device Displays Incorrect Message; Device Operates Differently Than Expected; Break; Failure to Deliver Energy; Device Displays Incorrect Message; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THE LEAD EXTENSION WAS NOT FRAYED AT THE TIME OF SURGERY. THE REP NOTED IT WAS BELIEVED IT BECAME FRAYED WHEN THE PATIENT HAD IT COME OUT OF THE DRESSING. IT WAS NOTED THE PATIENT HAD THE DRESSING REPLACED AND THE NEXT DAY IT WAS COMING UNDONE AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient; Therapeutic Effects, Unexpected

  MAUDE report 6322230 ↗
• MalfunctionJan 12, 2017High impedance; Device Displays Incorrect Message; Device Operates Differently Than Expected; High impedance; Device Displays Incorrect Message; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT ELECTRODE THREE WAS CAUSING AN OPEN CIRCUIT.

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

  MAUDE report 6247483 ↗
• InjuryDec 14, 2016Device Operates Differently Than Expected; Device Operates Differently Than Expected

  A HEALTHCARE PROFESSIONAL (HCP) REPORTED VIA MANUFACTURER REPRESENTATIVE (REP) THAT SHE WAS IN THE OPERATING ROOM (O.R) ON THE MORNING OF THE CALL. THE REP STATED THE HCP DECIDED TO REMOVE THE OLD ADVANCED EVALUATION LEAD AND RE-IMPLANT A NEW LEAD. THE REP REPORTED DURING THE TRIAL, THE PATIENT PULLED ON THEIR LEAD. THE REP NOTED THE HCP IMPLANTED FOR A NEW LEAD AND THE PATIENT WAS DOING FINE. THERE WERE NO SYMPTOMS REPORTED. ADDITIONAL INFORMATION FROM THE REP REPORTED THE PATIENT HAD COMPLETED AN ADVANCED EVALUATION AND HAD THE PERMANENT DEVICE IMPLANTED ON (B)(6) 2016. IT WAS NOTED THE PATIENT HAD BI-LATERAL IMPLANTS. THE INDICATION FOR USE IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6174419 ↗

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