NA 97745Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000241988), received between Jun 9, 2023 and Jun 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Charging Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2023Failure to Interrogate; Overheating of Device; Delayed Charge Time; Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information; Failure to Interrogate; Overheating of Device; Delayed Charge Time; Charging Problem; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. THE REASON FOR CALL WAS PT EXPRESSED FRUSTRATION BECAUSE CHARGING HIS IMPLANT HAS BECOME VERY DIFFICULT. PT SAID HE HAS THOSE FUNKY MESSAGES AND NOTICED LAST NIGHT HE CHARGED FOR 3 HOURS BUT IT ONLY WENT FROM 30 TO 70 % IN 3 HOURS WITH THE LIGHT FLASHING GREEN. PT SAID HE HAS NOTICED HEATING ON THE DONUT BUT DOES NOT HAVE A BELT AND RECHARGES IN A RECLINING SLEEP CHAIR, LEANING AGAINST THE RECHARGE ANTENNA. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED AS REVIEWED SOME RECHARGING BEST PRACTICES INSTEAD. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED HE SAID HE WAS A LARGE MAN. NO SYMPTOMS WERE REPORTED. THE PATIENT CALLED TO REPORT THAT HE LOOKED EVERYWHERE FOR THE PACKAGE FROM REPAIR BUT HE WAS UNABLE TO FIND IT. THEY CALLED BACK IN AND STATED THAT HE NEVER RECEIVED THE RECHARGER CORD THAT WAS SENT. IT WAS THEN CONFIRMED THE RTM REPLACEMENT WAS DELIVERED ON (B)(6) 2020. THEY STATED THAT HE HAD 2 CONTROLLERS AND HE USED THE SECOND CONTROLLER WHEN HE DID NOT RECEIVE THE RECHARGER AND THE ISSUE RESOLVED UNTIL RECENTLY AND NOW HE WAS GETTING THE SAME ISSUES CHARGING HIS INS BATTERY. THEY REPEATED THAT HE IS GETTI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097916 ↗

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