NA 3708240 (UDI 00885074404516)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885074404516), received between Feb 24, 2017 and Sep 30, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2021Impedance Problem; Impedance Problem

  THE PATIENT REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT THEY HAD A LIMITED RANGE OF MOTION IN THE NECK. THE PATIENT HAD THEIR IMPLANT BATTERY REPLACED LAST WEEK DUE TO NORMAL BATTERY DEPLETION AND THE SUBSEQUENT REPOSITION OF THE LEAD-EXTENSION CONNECTION RESULTED IN THE LIMITED RANGE OF MOTION. A REVISION WAS PERFORMED ON 27-SEP TO POSITION THE CONNECTORS AGAIN TO PROVIDE MORE SLACK IN THE SYSTEM. AN IMPEDANCE CHECK SHOWED A WARNING FOR THE 8-9 ELECTRODE PAIR. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT AND A FOLLOW-UP WAS GOING TO BE DONE TO ENSURE NO PROGRAMMING WAS NEEDED TO ACCOMMODATE THE IMPEDANCE ISSUE.

  Patient problems: Loss of Range of Motion

  MAUDE report 12555735 ↗
• InjuryFeb 22, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTI MULATOR (INS) FOR CHRONIC LOW BACK PAIN AND RADICULOPATHY. IT WAS REPORTED THAT THE THE REP FOUND OUT THAT SEVERAL YEARS AGO THE ORIGINAL INS WAS REPLACED BY A COMPETING MANUFACTURER'S INS AND CONNECTED TO OUR EXTENSION AND LEAD. CASE WAS SCHEDULED FOR NORMAL END OF LIFE REPLACEMENT. UPON X-RAYS IN THE OR, WE SAW THAT EXTENSION WAS FRACTURED. REMOVED EXTENSION AND WHEN DISCONNECTING FROM LEAD THE WIRES WERE STARTING TO FRAY WHEN PULLING OUT OF THE EXTENSION. UNABLE TO CONNECT NEW EXTENSION TO EXISTING LEAD AS THE LEAD WIRE WAS DAMAGED. THE HEALTHCARE PROVIDER (HCP) REMOVED ENTIRE SYSTEM AND WILL SCHEDULE PATIENT TO COME BACK AT A FUTURE DATE FOR A FULL IMPLANT WITH A 2/8 SURGICAL PADDLE LEAD. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11359234 ↗
• InjuryFeb 24, 2017Break; Device Operates Differently Than Expected; Impedance Problem; Break; Device Operates Differently Than Expected; Impedance Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT. IT WAS REPORTED THAT THERE WAS A REVISION SURGERY TO REPLACE AN EXTENSION IN (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6358959 ↗

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