NA 3778-60 (UDI 00613994721945)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994721945), received between Oct 13, 2020 and Sep 24, 2021 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2021Break; Connection Problem; Break; Connection Problem

  THE MANUFACTURER REPRESENTATIVE REPORTED THAT DURING A REPLACEMENT SURGERY ONE OF THE LEADS WOULD NOT RESEAT INTO THE NEW BATTERY PORT. BOTH PORTS WERE ATTEMPTED BEFORE ONE PORT WAS PLUGGED AND THE LEAD WAS LEFT IN THE PATIENT. THE OTHER LEAD WAS WORKING FINE WITH HIGH IMPEDANCES ONLY ON ELECTRODE 6. IT WAS NOTED THAT 90% OF THE PROGRAMMING HAD BEEN ON THE FUNCTIONING LEAD PRIOR TO REPLACEMENT SO THEY WERE ABLE TO RETAIN GOOD COVERAGE POST-OPERATIVELY. THERE WERE NO KNOWN EXTERNAL OR PATIENT FACTORS THE CONTRIBUTED TO THE ISSUE. WHEN COMPARING THE SIZE AND APPEARANCE OF THE LEADS ONE ELECTRODE ON THE LEAD THAT DID NOT RESEAT APPEARED TO BE BENT. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526567 ↗
• MalfunctionOct 13, 2020Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT TWO ELECTRODES BROKE OFF OF THE LEAD. THERE WERE NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED, OR CONTRIBUTED TO THE ISSUE. THE PATIENT WENT INTO SURGERY FOR A NORMAL EOS OF BATTERY. THE PATIENT AND PHYSICIAN WANTED TO REPLACE THE ENTIRE SYSTEM TO BE MRI COMPATIBLE. WHILE REMOVING THE OLD LEAD TWO ELECTRODES BROKE OFF IN THE BATTERY POCKET WHILE PULLING OUT THROUGH THE POCKET. AN X-RAY WAS TAKEN TO CONFIRM WHERE THE ELECTRODES WERE. THEY WERE DETERMINED TO BE IN THE POCKET WHERE THERE BATTERY SAT, AND THE PHYSICIAN WAS ABLE TO RETRIEVE THEM. THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10670497 ↗

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