NA 97725 (UDI 00763000258115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000258115), received between Sep 21, 2020 and Dec 15, 2021 — classified as 8 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (5 reports).

9 other recalls cover devices cleared under the same FDA submission (P840001); 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 15, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM A REP REGARDING A TRAIL PATIENT. IT WAS REPORTED THAT IN THE NOTES, FROM THE TRIAL, ONE OF THE LEADS DID MIGRATE DOWN; LOOKS LIKE TO THE NORTH. PT STILL HAD A VERY SUCCESSFUL TRIAL AND AN IMPLANT WAS DONE. THE DATE OF LEAD PULL WAS WHEN REP BECAME AWARE OF TRIAL LEAD MIGRATION. (B)(6) 2021. SERIAL NUMBER OF THE TRIAL LEAD AND ENS WILL HAVE TO BE LOOKED UP, REP REQUESTED AN EMAIL FOR THAT. NO OTHER WARNING ISSUES DURING TRIAL AND REP WOULD NOT HAVE ASKED PT TO DISREGARD ANY WARNINGS. (B)(6) 2021 IT WAS REPORTED THAT THE CAUSE OF LEAD MIGRATION WAS UNKNOWN. PATIENT TRIAL WAS SUCCESSFUL 80% RELIEF SO LEADS WERE DETER TO NOT BE DAMAGED AND THEREFORE NOT RETURNED. PATIENT WEIGHT IS UNKNOWN. THIS INFORMATION HAS BEEN CONFIRMED WITH HCP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13009376 ↗
• MalfunctionAug 10, 2021High impedance; High impedance

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT (PT) WHO WAS USING WIRELESS EXTERNAL NEUROSTIMULATOR (WENS). IT WAS REPORTED THAT DURING INTRAOP TESTING, WE WERE GETTING MULTIPLE OPEN CIRCUIT READINGS, AND HIGH IMPEDANCE READINGS. TRIED WIPING THE LEAD SEVERAL TIMES, AND SWITCHING CHANNELS TO DETERMINE IF IT WAS THE LEAD OR THE WENS WITH NO SUCCESS. THE HCP INSTRUCTED REP TO SWAP OUT THE WENS. AFTER SWITCHING TO A NEW WENS, THE LEAD SHOWED MORE OPEN CIRCUITS AND HIGH IMPEDANCE ISSUES AT MULTIPLE CONTACTS, MAINLY THE 4 MOST DISTAL CONTACTS. SWITCHED OUT THE LEAD WITH A NEW ONE. THE ISSUE WAS RESOLVED. IT¿S POSSIBLE THE LEAD WAS DAMAGED WHEN THE HCP TRIED TO BEND THE STYLET TO HAVE MORE CURVATURE. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304759 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT THEY WERE TO START A TRIAL WITH THIS PT ON (B)(6) 2021, BUT THE TRIAL WAS ABORTED BECAUSE THE PT HAD PAIN IN THE LEGS THAT THEY COULDN'T TOLERATE WHEN THE DOCTOR WAS ADVANCING THE TRIAL LEAD.  NO DEVICE ISSUES WERE REPORTED. THE MANUFACTURER REPRESENTATIVE HAS NO FURTHER INFORMATION REGARDING THE EVENT AS SHE WAS TOLD TO LEAVE AS THEY WERE WAITING FOR THE AMBULANCE TO ARRIVE TO THE OFFICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THAT THE CAUSE OF THE PAIN DURING PLACEMENT WAS UNCLEAR ETIOLOGY. THE TRIAL WAS ABORTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WORKUP WAS NEGATIVE. THE ISSUE WAS RESOLVED WITH PAIN CONTROL WITH MEDS. PSYCH CONSULT. THE DEVICES WERE DISCARDED.

  Patient problems: Pain

  MAUDE report 12061503 ↗
• MalfunctionJun 17, 2021Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A TRIAL PATIENT WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR OTHER CHRONIC/INTRACT PAIN (TRUNK/LIMBS). IT WAS REPORTED THAT THERE¿WAS NOT A COMPLAINT, HOWEVER, DURING A NORMAL END OF LIFE REPLACEMENT OF HIS IPG, IMPEDANCE TESTING SHOWED ALL CONTACT OUT OF RANGE ON 0-7.¿THE LEAD WAS PULLED OUT AND WIPED DOWN SEVERAL TIMES. IT WAS MOVED TO 8-15 HEADER. WE ALSO TESTING WITH A WENS. EVERY TIME ALL CONTACTS WERE OOR.¿THEY TURNED ON THE OTHER LEAD AND IT WAS GIVING THE PATIENT GOOD STIMULATION OF HIS PAINFUL AREAS, SO THE MD CHOSE TO MOVE FORWARD WITH THE IPG REPLACEMENT AND NOT REVISE THE LEAD. THE ISSUE WAS REPORTED TO BE RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12020466 ↗
• InjuryJun 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE CAUSE OF THE PATIENT FEELING SICK WAS THAT THE PATIENT HAD TAKEN MORE PAIN MEDS THAN SHE WAS SUPPOSED TO AND WAS NOT EATING WHILE TAKING HER ANTIBIOTICS. PATIENT WAS TAKING ANTIBIOTICS BECAUSE OF HER STIM TRIAL. THE PROVIDER HAS PRESCRIBED THEM FOR THE TRIAL.

  Patient problems: Malaise

  MAUDE report 11929970 ↗
• InjuryMay 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL REVIEW OF THE ORIGINAL SOURCE DOCUMENT INDICATED THAT THE PATIENT HAD THE EPIDURAL ABSCESS AFTER THE TRIAL. IT WAS NOTED THAT THE EPIDURAL ABSCESS HAD TO BE REMOVED SURGICALLY.

  Patient problems: Abscess; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11793302 ↗
• InjuryApr 14, 2021Impedance Problem; Impedance Problem

  ADDITIONAL INFORMATION FROM THE REP INDICATED THAT THE DEVICE STATUS IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11664347 ↗
• InjuryFeb 23, 2021Positioning Problem; Positioning Problem

  THE CAUSE OF THE BURNING, TINGLING, AND PAIN IN BOTH LEGS WAS NOT DETERMINED. THE PATIENT WENT TO THE HOSPITAL FOLLOWING THIS TO HAVE TESTING DONE.

  Patient problems: Burning Sensation; Pain; Paresthesia

  MAUDE report 11365979 ↗
• InjuryJan 28, 2021Impedance Problem; Impedance Problem

  ON (B)(6) 2021, IT WAS REPORTED THAT DURING PLACEMENT OF A TRIAL LEAD, THE LEAD SHOWED "RED" ON SOME CONTACTS. THE MANUFACTURER REPRESENTATIVE SWAPPED LEAD IN WIRELESS EXTERNAL NEUROSTIMULATOR PORT AND ISSUE REMAINED WITH THE LEAD. THE HEALTH CARE PROFESSIONAL REQUESTED A NEW LEAD BE USED. THE SAME WIRELESS EXTERNAL NEUROSTIMULATOR WAS USED TO COMPLETE THE TRIAL SUCCESSFULLY. ON (B)(6) 2021, ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE LEAD IN QUESTION W AS RETURNED ON FRIDAY, (B)(6) 2021 AND THE TRACKING NUMBER OF THE DEVICE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11248093 ↗
• InjuryJan 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPRESENTATIVE STATED THAT ACCORDING TO THE PHYSICIAN THE PATIENT¿S HEADACHE HAD IMPROVED SINCE THE BLOOD PATCH.

  Patient problems: Cerebrospinal Fluid Leakage; Headache

  MAUDE report 11234855 ↗
• MalfunctionDec 9, 2020Human-Device Interface Problem; Impedance Problem; Human-Device Interface Problem; Impedance Problem

  THE REP REPORTED ON (B)(6) 2020 THAT A TOTAL OF 3 LEADS AND 2 WENS WERE ASSOCIATED WITH THIS TRIAL. THE FIRST WENS AND 1ST LEAD USED THAT HAD CONNECTIVITY ISSUES INTRA-OP WERE THE DEVICES THAT WERE RETURNED FOR ANALYSIS. DURING THE TRIAL, THE PATIENT HAD USED THE 2ND WENS THAT WAS NOT RETURNED ALONG WITH 2 LEADS. WHEN THE PATIENT WENT TO POST-OP, THE CONNECTIVITY AND IMPEDANCES WERE CHECKED AGAIN AND WERE FOUND TO BE RESOLVED. THE PATIENT CONTINUED ON WITH THE TRIAL, WHICH WENT WELL. THE WENS AND TWO LEADS THAT WERE USED DURING THE TRIAL WERE NOT RETURNED TO THE REP, SO THEY WEREN'T SENT BACK FOR ANALYSIS. THE REP STATED EITHER THEY WERE DISCARDED OR WERE STILL IN THE POSSESSION OF THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10977204 ↗
• MalfunctionDec 9, 2020Human-Device Interface Problem; Impedance Problem; Human-Device Interface Problem; Impedance Problem

  DURING A TRIAL, TWO DIFFERENT TRIAL LEADS WERE USED WITH TWO DIFFERENT WIRELESS EXTERNAL NEUROSTIMULATORS AND THEY COULD NOT GET THE CONNECTIVITY CHECK TO SHOW ALL GREEN. AT MOST, THEY GOT 4 GREEN CONNECTIONS. THEY PULLED THE INITIAL LEAD AND PUT IN THE NEW ONE AND IT WAS DISPLAYING THE SAME 4 CONTACTS AS COMPROMISED; HOWEVER, THE MANUFACTURER REPRESENTATIVE WASN'T DOING A QUAD LEAD CONFIGURATION. THEY TRIED BOTH LEADS WITH BOTH WIRELESS EXTERNAL NEUROSTIMULATORS AND BOTH PORTS ON THE WIRELESS EXTERNAL NEUROSTIMULATORS. THEY RAN AN ELECTRODE IMPEDANCE CHECK AND THEY WERE SEEING "DO NOT USE" FOR MOST OF THE CONTACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10977184 ↗
• InjuryDec 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A PATIENT, A MANUFACTURER REPRESENTATIVE, AND A HEALTH CARE PROFESSIONAL. IT WAS REPORTED THAT THE PATIENT STARTED A SPINAL CORD STIMULATION TRIAL WITH ONE LEAD ON (B)(6) 2020 TO ADDRESS BACK PAIN. THE PATIENT ALSO HAS PRE-EXISTING NECK PAIN AS WELL. ON (B)(6) 2020, THE PATIENT STARTED GETTING INCREASED NECK PAIN AND A HEADACHE THAT WAS BAD ENOUGH THAT THE PATIENT WENT TO THE HOSPITAL FOR CARE. THE PATIENT WAS SEEN AT THE HOSPITAL, BUT SENT HOME. THE PATIENT WENT BACK TO THE HOSPITAL ON (B)(6) 2020 AND WAS HOSPITALIZED WITH A SUSPECTED INFECTION. THE MANUFACTURER REPRESENTATIVE SPOKE WITH A NURSE AND THE PATIENT HAD AN ELEVATED WHITE CELL COUNT AND THEY WERE PLANNING TO DO A LUMBAR PUNCTURE TO DETERMINE THE SOURCE OF INFECTION. THE LEAD WAS STILL INTERNALIZED, AND THE HOSPITAL DID NOT WANT TO TAKE SOMETHING OUT THAT THEY HAD NOT PLACED. THE HOSPITAL WAS GOING TO GET A NEUROSURGEON INVOLVED TO REMOVE THE LEAD. ON (B)(6) 2020, THEY STILL HAD NOT DONE A LUMBAR PUNCTURE. THE PATIENT WAS STILL IN THE HOSPITAL AS OF (B)(6) 2020, AND NO LUMBAR PUNCTURE HAD BEEN DONE, BUT THE LEAD HAD BEEN REMOVED. THE PATIENT WAS DIAGNOSED WITH PRESUMED MENINGITIS. THE PATIEN

  Patient problems: Headache; Meningitis; Pain; Unspecified Infection

  MAUDE report 10971122 ↗
• MalfunctionNov 17, 2020High impedance; Device Contamination with Chemical or Other Material; High impedance; Device Contamination with Chemical or Other Material

  THE MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT THERE WERE HIGH IMPEDANCES SHOWING IN BOTH CHANNELS DURING INTRA-OP TESTING. THEY STATED THAT THERE WAS A LARGE AMOUNT OF FLUID IN THE EPIDURAL CANAL. THE REP RAN IMPEDANCES AND THEN SWITCHED TO THE OPPOSITE CHANNEL, BUT THE ISSUE WAS NOT RESOLVED. THE REP STATED THAT THE PERCUTANEOUS TRIAL LEAD WAS REPLACED WITH A NEW TRIAL LEAD TO RESOLVE THE ISSUE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10852054 ↗
• MalfunctionNov 2, 2020High impedance; High impedance

  FURTHER REVIEW INDICATED THE EVENT WAS REPORTED IN ERROR. THE HIGH IMPEDANCES WERE NEVER REPORTED AS OUT OF RANGE, THE LEAD WAS STILL USED, IT WAS A TRIAL WIRELESS EXTERNAL NEUROSTIMULATOR (WENS) THAT WAS REPLACED, AND THE IMPEDANCES RESOLVED IN RECOVERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10770708 ↗
• MalfunctionSep 21, 2020Failure to Interrogate; Energy Output Problem; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem; Failure to Interrogate; Energy Output Problem; Therapy Delivered to Incorrect Body Area; Inappropriate/Inadequate Shock/Stimulation; Communication or Transmission Problem

  REP REPORTED THE PATIENT HAD A FAILED TRIAL BECAUSE HE SAID THE STIMULATOR SHOCKED HIM AND THAT THE REMOTE WAS NOT COMMUNICATING WITH THE DEVICE. PATIENT WAS COMPLAINING THAT HE THINKS THE STIMULATOR BURNED HIS KIDNEYS. THE HCP REQUESTED ANY INFORMATION THAT THE STIMULATOR COULD "BURN" ANY NERVES BECAUSE THE HCP DOES NOT THINK THAT'S POSSIBLE AND WOULD LIKE TO PROVIDE THE PATIENT WITH SOME INFORMATION. PATIENT REPORTED ORGAN PAIN AFTER THE TRIAL. THE PATIENT FELT OVERSTIMULATED DURING THE TRIAL. THE PATIENT CLAIMED THEY FELT STIM IN THE KIDNEYS. THE REMOTE STOPPED COMMUNICATING WITH THE STIMULATOR DURING THE TRIAL, SO THE BATTERIES WERE REMOVED TO STOP THE UNCOMFORTABLE STIM. MANY MONTHS AFTER THE TRIAL THE PATIENT CLAIMED TO HAVE RESIDUAL KIDNEY PAIN. THE HCP SUSPECTED THE PATIENT WAS LOOKING FOR A PAIN MED PRESCRIPTION. IT WAS CLARIFIED THE ISSUE WAS NOT HEATING AT THE INS SITE, BUT THE PATIENT SAYING THE STIMULATION FROM THE LEADS BURNED HIS KIDNEYS.

  Patient problems: Burn(s); Discomfort; Electric Shock; Fall; Pain; Undesired Nerve Stimulation

  MAUDE report 10560584 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001. 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-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1926-2016 · May 3, 2016 · Terminated
  Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or li
• 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-1524-2014 · Feb 27, 2014 · Terminated
  Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced
• Z-0278-2014 · Sep 30, 2013 · Terminated
  Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
• Z-1536-06 · Aug 2, 2006 · Terminated
  Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis