NA 3778-60 (UDI 00613994188670)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994188670), received between Feb 22, 2017 and Feb 27, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Failure to Deliver Energy” (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.

• InjuryFeb 27, 2017Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  A PATIENT REPORTED VIA MANUFACTURER REPRESENTATIVE THAT AFTER A RECENT IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY ON (B)(6) 2017, HE WAS UNABLE TO FEEL ANY STIMULATION. UPON INTERROGATING THE DEVICE, ALL ELECTRODES WERE FOUND TO BE OUT OF ORDER, >10,000 OHMS. THE LEAD WAS REPLACED WITH A SURGICAL PADDLE ON (B)(6) 2017. THE ISSUE WAS RESOLVED. THE INDICATION FOR IMPLANT WAS FAILED BACK SURGERY SYNDROME AND SPINAL PAIN.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 6362702 ↗
• InjuryFeb 22, 2017Failure to Deliver Energy; High impedance; Failure to Deliver Energy; High impedance

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL THROUGH A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF STIMULATION AND THE LEAD WAS FOUND TO HAVE OUT OF RANGE IMPEDANCES. THE LEAD WILL BE REPLACED ON (B)(6) 2017.

  Patient problems: Therapeutic Effects, Unexpected

  MAUDE report 6348937 ↗

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