NA 3777-45 (UDI 00613994188632)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994188632), received between Dec 4, 2018 and Jun 21, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT REPORTED A LEAD ISSUE. THE PATIENT¿S SPINE WAS TWISTED TO THE RIGHT AND THERE WAS AN ISSUE WITH THE RIGHT LEAD. HE NEEDED ANOTHER REVISION. HE WAS BEING GIVEN FULL BODY ELECTRICAL SONIC PULSES ON EACH OF HIS 3 LEADS BEFORE TRYING ANOTHER SURGERY TO REVISE. RELEVANT MEDICAL HISTORY INCLUDED CERVICAL RADICULOPATHY. FOLLOW-UP WAS PERFORMED TO DETERMINE WHAT HAD LED TO THE LEAD ISSUE, IF THE LEAD ISSUE WAS CONFIRMED AND WHAT IT WAS SPECIFICALLY, AND WHAT ACTIONS WERE TAKEN TO ADDRESS THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8722210 ↗
• InjuryDec 4, 2018Break; Break

  INFORMATION WAS RECEIVED FROM A CONSUMER WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR POST LUMBAR LAMINECTOMY. IT WAS REPORTED THAT ONE OF THE LEADS WAS BROKEN AND NEEDED TO BE REPLACED WITH A NEW ONE. THE PATIENT WAS WAITING FOR HER APPOINTMENT TO SCHEDULE THE NEXT PROCEDURE. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8129691 ↗

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