NA 97754 (UDI 00643169518971)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169518971), received between Jul 28, 2017 and Jul 28, 2017 — 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.

• MalfunctionJul 28, 2017Charging Problem; Charging Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT'S RECHARGER IS INCONSISTENT AND SOMETIMES IT WILL CHARGE FULLY, OTHER TIMES THEIR BATTERY WILL NO CHARGE. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT¿S APPOINTMENT WAS CANCELED AND HAD NOT BEEN RESCHEDULED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT A PATIENT STATED IT NEVER RECHARGES THE WHOLE WAY. THE PATIENT MENTIONED THE PROGRAMMER BATTERIES WERE DEAD AND HAD TO REPLACE. PATIENT SERVICES (PS) ASKED TO CLARIFY IF THE ISSUE WAS WITH RECHARGER/ PROGRAMMER. THE PATIENT COULD NOT CLARIFY AND STATED THE RECHARGER HOWEVER KEPT REVERTING BACK TO BATTERIES. PS HAD PATIENT SET UP EQUIPMENT AND PATIENT WAS GETTING ALL 8 BOXES AND WAS SHOWING HALF CHARGED ACCORDING TO THE PATIENT PROGRAMMER AND RECHARGER. PS ADVISED TO CONTINUE TO CHARGE AND CALL BACK IF THE PROBLEM DOES CONTINUE AND MAKE APPOINTMENT WITH MANUFACTURING REPRESENTATIV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6750131 ↗

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