N/A 97745NT (UDI 00763000635145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000635145), received between Dec 27, 2023 and Dec 27, 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.

• MalfunctionDec 27, 2023Failure to Power Up; Charging Problem; Connection Problem; Failure to Power Up; Charging Problem; Connection Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS R EPORTED THAT THE PATIENT CAN'T CHARGE UP CONTROLLER FOR "ABOUT THE LAST WEEK AND A HALF OR TWO WEEKS AGO." RESETTING CONTROLLER DIDN'T FIX ISSUE. CONTROLLER WONT POWER ON WITH BATTERY PACK OUT AND AC POWER PLUGGED IN, AND THE GREEN LIGHT IS ON, ON AC POWER PLUG. DURING THE CALL THEY PUT IN AA BATTERIES AND SCREEN DOES COME ON. CONTROLLER PORT HAS A FEW PINS IN THE CENTER THAT LOOK BLACKENED OUT. THE ISSUE WAS NOT RESOLVED. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE CONTROLLER. PATIENT CALLED BACK AND STATED THEY RECEIVED THE REPLACEMENT CONTROLLER, BUT THE CONTROLLER IS STILL NOT POWERING ON WITH THEIR ORIGINAL BATTERY PACK OR THE AC POWER SUPPLY CONNECTED. PATIENT STATED THEIR REPLACEMENT CONTROLLER POWERS ON WITH AA BATTERIES INSERTED. AGENT HAD PATIENT REMOVE THE BATTERIES FROM THE REPLACEMENT CONTROLLER AND CONNECT TO THE AC POWER SUPPLY; THE CONTROLLER DID NOT POWER ON. AGENT SENT AN EMAIL TO REPAIR TO REPLACE THE AC POWER SUPPLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18399919 ↗

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