NA 97754 (UDI 00643169585928)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169585928), received between Jun 6, 2017 and Nov 8, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2023Charging Problem; Connection Problem; Material Integrity Problem; Charging Problem; Connection Problem; Material Integrity Problem

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE CALLER HAD A BROKEN DESKTOP CHARGER (DTC) CONNECTOR PIN. PT REPORTED THE PIN BROKE OFF AND WAS STUCK INSIDE THE RECHARGER. PT SAID THEY TRIED TO REMOVE PIN WITH A PLIERS, BUT COULD NOT GET THE PIN OUT AND THEREFORE PT COULD NOT CHARGE. NO SYMPTOMS OR PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096596 ↗
• MalfunctionSep 22, 2017Device Displays Incorrect Message; Charging Problem; Connection Problem; Device Displays Incorrect Message; Charging Problem; Connection Problem

  INFORMATION WAS RECEIVED REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS), AND IT WAS REPORTED THAT THE PATIENT SAW A SCREEN WITH A PICTURE OF A CORD, AND THINKS IT MIGHT BE THE "CHARGE THE RECHARGER" SCREEN, BUT WAS NOT SURE. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT HAD ALL THE COMPONENTS, AND WAS UNABLE TO CHARGE AS THE ARROWS DID NOT LINE UP. IT WAS DETERMINED THE DESKTOP CHARGER WAS PLUGGED IN BACKWARDS AND THE RECHARGER CONNECTOR WAS DAMAGED. PATIENT WAS ISSUED A NEW RECHARGER AND DESKTOP CHARGER. NO SYMPTOMS WERE REPORTED. THERE WERE NO REPORTED COMPLICATIONS AND NO FURTHER COMPLICATIONS WERE EXPECTED. PATIENT WAS IMPLANTED FOR NON-MALIGNANT PAIN. ADDITIONAL INFORMATION: INFORMATION WAS REPORTED THAT THE PATIENT HAS NEVER BEEN ABLE TO FULLY CHARGE. THE PATIENT RECEIVED NEW INS RECHARGER EQUIPMENT THE PATIENT RECEIVED RESOLVED THE ISSUES WITH THE RECHARGER. NO FURTHER COMPLICATIONS WERE REPORTED. NO PATIENT SYMPTOMS WERE REPORTED RELATED TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6886497 ↗
• InjurySep 19, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THE INS RECHARGER (INSR) STARTED MAKING NOISES AND ACTING CRAZY LIKE IT HAD BEFORE. THE PATIENT STATED THEY WERE ATTEMPTING TO RESET THE INSR TO RESOLVE THE ISSUE, BUT THE SCREWDRIVER SLIPPED IN THEIR HAND. THE PATIENT STATED THEY HAVE LIMITED FUNCTIONALITY WITH THEIR HANDS BECAUSE OF THEIR COMPLEX REGIONAL PAIN SYNDROME FROM PREVIOUS BACK SURGERIES UNRELATED TO THE DEVICE. THE PATIENT STATED REMOVING THE SCREW WAS DIFFICULT FOR THEM, AND WHEN THE SCREWDRIVER SLIPPED, IT STABBED THEIR RIGHT THUMB AND THERE WAS BLOOD ALL OVER THE PLACE. THE PATIENT SPENT THE NIGHT IN THE EMERGENCY ROOM AND THEY NEEDED STITCHES. THE PATIENT MENTIONED THE SCREW COULD BE LARGER WITH A LARGER HOLE TO RESET THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. IT WAS REPORTED THAT THE PATIENT HAD TO GO TO THEIR NEIGHBOR'S ON (B)(6) 2017 TO RESET THEIR INSR 13 TIMES. THE PATIENT WAS VERY UPSET THAT THE FIELD STAFF HAD NOT CONTACTED THEM AND WAS SPEAKING WITH AN ATTORNEY. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6876441 ↗
• MalfunctionJun 6, 2017Overheating of Device; Overheating of Device

  (SEE (B)(4) FOR ALLEGATIONS OF INSR BEEPING AND HARD RESET.)

  Patient problems: Burn(s); Burn, Thermal

  MAUDE report 6614572 ↗

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