NA 3778-60 (UDI 00643169157330)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169157330), received between Jan 13, 2017 and May 24, 2024 — classified as 3 injuries, 3 malfunctions.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEADS WERE ERODING OUT OF THE SKIN. THE DOCTOR CUT AND REMOVED WHAT THEY COULD. THE CAUSE WAS NOT KNOWN AND THE ISSUE WAS RESOLVED. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR HAD PREVIOUSLY BEEN REMOVED.

  Patient problems: Erosion

  MAUDE report 19392191 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE LEADS WERE ERODING OUT OF THE SKIN. THE DOCTOR CUT AND REMOVED WHAT THEY COULD. THE CAUSE WAS NOT KNOWN AND THE ISSUE WAS RESOLVED. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR HAD PREVIOUSLY BEEN REMOVED.

  Patient problems: Erosion

  MAUDE report 19392087 ↗
• MalfunctionJun 15, 2023High impedance; High impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THEY HAVE BEEN ABLE TO WORK AROUND THE CONTACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136810 ↗
• MalfunctionApr 22, 2019Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  REFER TO REGULATORY REPORT # 6000153-2019-00006.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 8535460 ↗
• InjuryApr 22, 2019Break; Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information; Break; Migration or Expulsion of Device; Inappropriate/Inadequate Shock/Stimulation; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR FOR NON-MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT THE LEADS HAD BROKEN AND WERE OUT OF PLACE. THE PATIENT HAD THE LEADS REPLACED. THE PATIENT REPORTED THAT A FEW BROKEN AT FIRST, AND THERE WAS A SHOCK AND IT STOPPED WORKING. A LEAD REVISION WAS DONE, AND THE LEADS WERE REPLACED.

  Patient problems: Electric Shock; Therapeutic Effects, Unexpected

  MAUDE report 8535440 ↗
• MalfunctionJan 13, 2017Failure to Deliver Energy; Therapy Delivered to Incorrect Body Area; Device Operates Differently Than Expected; Failure to Deliver Energy; Therapy Delivered to Incorrect Body Area; Device Operates Differently Than Expected

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP REPORTING THAT THE PATIENT WAS REPROGRAMMED AND THEIR SCS SYSTEM AND THERAPY IS WORKING WELL. THE REP STATED THAT THERE WERE NO ISSUES WITH IMPEDANCE OR COVERAGE.

  Patient problems: Ambulation or Postural Difficulties; Complaint, Ill-Defined; Depression; Memory Loss/Impairment; Pain; Therapeutic Effects, Unexpected; Therapeutic Response, Decreased; Undesired Nerve Stimulation

  MAUDE report 6251931 ↗

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