NA 3777-60 (UDI 00643169157569)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169157569), received between Aug 8, 2017 and Aug 8, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• InjuryAug 8, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR OTHER NON-MALIGNANT PAIN AND SPINAL PAIN. INFORMATION WAS REPORTED THAT A PATIENT HAD WENT TO HER PAIN DOCTOR COMPLAINING OF PAIN AT AN OLD INCISION SITE. THERE WERE NO REPORTED FACTORS THAT MAY HAVE CLOSED THIS ISSUE (FALLS, EMI, PATIENT COMPLIANCE). AN X-RAY WAS TAKEN OF THE AREA WHERE SHE HAD PAIN AND NOTHING ABNORMAL SEEN. SURGERY TO EXPLORE CAUSE OF PAIN WAS DONE AT SITE OF PREVIOUS INCISION. SCAR TISSUE HAD DEVELOPED AROUND LEAD AND THIS IS WHAT WAS THOUGHT TO BE CAUSING PAIN. SCAR TISSUE WAS REMOVED. THE ISSUE HAD BEEN RESOLVED AT THE TIME OF THIS REPORT. NO FURTHER COMPLICATIONS WERE REPORTED. NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: Pain

  MAUDE report 6775093 ↗

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