NA 97754 (UDI 00643169109469)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169109469), received between Nov 22, 2016 and Sep 20, 2017 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2017Failure to Interrogate; Device Displays Incorrect Message; Charging Problem; Communication or Transmission Problem; Failure to Interrogate; Device Displays Incorrect Message; Charging Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR FOR NON-MALIGNANT PAIN, POST LUMBAR LAMINECTOMY SYNDROME. IT WAS REPORTED THAT THE DESKTOP CHARGER HAD A BROKEN CONNECTOR PIN AND THE MANUFACTURING REPRESENTATIVE WOULD NOT INSPECT THE RECHARGER FOR DAMAGE. THE RECHARGER WAS UNABLE TO CHARGE NORMALLY. NO PATIENT INJURY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. ADDITIONAL INFORMATION: IT WAS REPORTED THAT A PATIENT CAN'T CHARGE HER INS BECAUSE ALL SHE GETS IS THE REPOSITION ANTENNA SCREEN ON THE RECHARGER. PATIENT STATED THAT SHE HAD CALLED HER MANUFACTURING REPRESENTATIVE (REP), ABOUT THE REPOSITION ANTENNA ISSUE. PATIENT STATED THAT HER CONNECTOR PIN HAD BROKEN PREVIOUSLY AND THE REP HAD CALLED PATIENT SERVICES FOR HER AND SHE WAS SENT A REPLACEMENT DESK TOP CHARGER (DTC) THAT SHE RECEIVED FRIDAY ((B)(6) 2017) AND PATIENT SAID SHE TOLD THE REP THAT SHE RECEIVED THE REPLACEMENT DTC, BUT THE REPLACEMENT DIDN'T RESOLVE THE ISSUE OF THE 'REPOSITION ANTENNA SCREEN' SHE WAS SEEING. PATIENT SAID THAT THE REP TOLD HER TO CALL TO GET A NEW RECHARGER AND TOLD HER THAT HE WOULD MEET UP WITH HER THIS

  Patient problems: Pain; Therapeutic Response, Decreased

  MAUDE report 6880240 ↗
• MalfunctionNov 22, 2016Overheating of Device; Charging Problem; Overheating of Device; Charging Problem

  A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) REPORTED THAT HER CHARGING ANTENNA BECAME HOT WHEN IN USE. SHE VISITED HER HEALTHCARE PROVIDER (HCP) BECAUSE SHE WAS HAVING TROUBLE GETTING THE INS CHARGED, AS THE ANTENNA BURNS HER BACK AFTER CHARGING FOR AN HOUR, AND HER BACK BECOMES RED. THE PATIENT MET WITH A MANUFACTURER'S REPRESENTATIVE (REP) AT THE CLINIC AND CHARGED FOR AN HOUR WITH THE REP'S CHARGER, AND THE ANTENNA BECAME WARM BUT DID NOT GET TOO HOT. PATIENT DID NOT RECALL SEEING THE THERMOMETER ICON ON THE RECHARGER. PATIENT WAS IMPLANTED FOR NON-MALIGNANT PAIN.

  Patient problems: Burn, Thermal; Erythema

  MAUDE report 6121428 ↗

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