NA 37642 (UDI 00613994691392)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00613994691392), received between May 2, 2017 and Dec 13, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (3 reports).

20 other recalls cover devices cleared under the same FDA submission (H020007, H050003, P960009); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2022Failure to Power Up; Failure to Power Up

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE DEVICE GOT TURNED OFF BY ACCIDENT AND WAS RESOLVED THE FOLLOWING DAY.

  Patient problems: Insufficient Information

  MAUDE report 15973170 ↗
• MalfunctionJul 14, 2017Display or Visual Feedback Problem; Failure to Interrogate; Communication or Transmission Problem; Device Operates Differently Than Expected; Display or Visual Feedback Problem; Failure to Interrogate; Communication or Transmission Problem; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT PROGRAMMER WORKED SOMETIMES AND SOMETIMES IT DID NOT. THE CALLER WAS UNSURE IF IT WAS THE CABLE. WHEN THE PATIENT TRIED TO DECREASE THE STIMULATION IT WOULD NOT CONNECT, IT MADE A NOISE AND AN INFO SCREEN APPEARED. THE PROBLEM HAS GOTTEN WORSE. THE CALLER WAS UNSURE WHAT SCREEN IT SHOWED WHEN IT DIDN'T WORK. THE CALLER NOTED THEY WOULD CALL BACK WHEN THE PATIENT WAS AVAILABLE TO DETERMINE WHAT SCREEN CAME UP. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WAS POOR COMMUNICATION DUE TO THE PROGRAMMER, BEGINNING SEVERAL WEEKS AGO; THIS OCCURRED WITH AND WITHOUT THE ANTENNA. THE CALLER ALLEGED THE ANTENNA WAS DAMAGED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6714092 ↗
• MalfunctionJun 5, 2017Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT COULD NOT GET TELEMETRY WITH THE ANTENNA. THE PATIENT WAS ABLE TO GET TELEMETRY WITHOUT THE ANTENNA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6611710 ↗
• MalfunctionMay 2, 2017Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN SYMPTOMS. THE PATIENT REPORTED THAT THEY WERE HAVING A LOT OF DIFFICULTY MAKING THE PROGRAMMER WORK. THE PATIENT STATED THAT IT IS SPORADIC, BUT SOMETIMES IT WORKS FINE AND OTHER TIMES THEY HAVE TO MESS WITH IT FOR 5 MINUTES BEFORE IT WILL FINALLY FUNCTION AND GET TO THE THERAPY SCREEN. THE PATIENT CONFIRMED THE POOR COMMUNICATION SCREEN. THE PATIENT CONNECTED THE ANTENNA, TRIED TO SYNC AND IT DID NOT RESOLVE THE ISSUE. THE PATIENT THEN SYNCED WITH THE PROGRAMMER ON THE INS WITHOUT THE ANTENNA AND REPORTED THAT THE ISSUE WAS RESOLVED. THE PATIENT WAS SENT A REPLACEMENT DEVICE. THERE WERE NO SYMPTOMS REPORTED. NO COMPLICATIONS OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6538337 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, H050003, P960009. One submission often covers many models, so check the product and lot details in each record.

• Z-2241-2026 · May 13, 2026 · Open, Classified
  Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-2240-2026 · May 13, 2026 · Open, Classified
  Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-0206-2025 · Sep 24, 2024 · Open, Classified
  Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
• 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-0217-2024 · May 27, 2022 · Completed
  LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
• Z-1128-2022 · Mar 30, 2022 · Open, Classified
  Percept BrainSense Implantable Neurostimulator (INS), Model B35200
• Z-0418-2022 · Oct 19, 2021 · Open, Classified
  Model B35200 - Percept PC BrainSense Implantable Neurostimulator
• Z-0201-2022 · Sep 23, 2021 · Open, Classified
  Clinician Programmer Application (CPA) model A610 Clinician Software Application
• Z-1368-2021 · Mar 9, 2021 · Open, Classified
  A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.46
• Z-3069-2017 · Mar 17, 2017 · Terminated
  DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to
• Z-2645-2016 · Jun 23, 2016 · Terminated
  DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain
• Z-2602-2016 · Jun 10, 2016 · Terminated
  Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
• Z-1617-2015 · Apr 16, 2015 · Terminated
  Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
• Z-0279-2014 · Sep 30, 2013 · Terminated
  Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
• Z-1190-2013 · Feb 8, 2013 · Terminated
  Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system del

…and 5 more.