N/A 97745Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994926005), received between May 21, 2018 and Nov 17, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Computer Software 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2018Intermittent Continuity; Energy Output Problem; Intermittent Continuity; Energy Output Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER ABOUT AN IMPLANTABLE NEUROSTIMULATOR (INS) IMPLANTED FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD AN ISSUE WITH CONTROLLER WHERE THE AMPLITUDE WILL GO UP AND DOWN ON ITS OWN. THE PATIENT NOTED THAT THE INS WAS WORKING UNTIL THE (B)(6), WHEN THEY STARTED HAVING MAJOR BREAKTHROUGH PAIN AND COULD NOT WALK AND THEIR ANKLE GAVE OUT. THE PATIENT SAID THAT SHE THEN TOLD A REP ABOUT THIS, SHE SAYS SHE PUT A CALL IN ON (B)(6) AND THEN THEY TALKED TO THEM ON THE (B)(6) AND THEY TOLD THEM THAT MY ANKLE HAD GIVEN OUT AND MY BREAKTHROUGH PAIN, SO ON THE (B)(6) THEY HELPED ME ADJUST IT OVER THE PHONE. THE PATIENT SAID THAT IT WAS NOT KNOWN AT THIS TIME, BUT THE ISSUE OF THE PAIN RETURNING COULD BE DUE TO THE ISSUE OF THE STIMULATION HAS BEEN TURNING OFF ON ITS OWN AND THEY WANT ME TO GET THE CONTROLLER EXCHANGED. THE PATIENT STATED SHE SAW A DIFFERENT REP ON (B)(6) IN THE DOCTOR'S OFFICE AND THAT WAS WHEN THEY REALIZED THE STIMULATION WAS TURNING UP AND DOWN ON ITS OWN AND THEY REMEMBER THEN ON (B)(6) THEY SAW IT WAS AT 0.1V SO IT HAD BEEN TURNING UP AND DOWN ON ITS OWN. THE PATIENT SAYS THAT SHE MET WITH THE REP ON (B)(6), AND THEY WERE SUSPECTI

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 8082055 ↗
• MalfunctionMay 21, 2018Computer Software Problem; Failure to Power Up; Device Displays Incorrect Message; Computer Software Problem; Failure to Power Up; Device Displays Incorrect Message

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THAT A ¿SOFTWARE PROBLEM¿ MESSAGE WAS SEEN ON THE CONTROLLER. THE PATIENT INDICATED THE MESSAGE OCCURRED WHEN THEY USED THE CONTROLLER TO ATTEMPT TO TURN STIMULATION ON. THE REP SAID THIS HAS HAPPENED 3 TIMES. THE REP REPORTED THE PATIENT SEES THE SCREEN AND IT SHUTS DOWN FOR A WHILE, SO THEY CAN¿T USE THEIR STIMULATION. THEN, THEY TRY TO USE IT A COUPLE DAYS LATER AND IT TURNS BACK ON. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 7529520 ↗

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