NA 37642 (UDI 00643169273450)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169273450), received between Jun 5, 2017 and Aug 26, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2020Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  IT WAS REPORTED THAT PATIENT IS GETTING POOR COMMUNICATION WHEN USING THE PATIENT PROGRAMMER WITH AND WITHOUT THE CONTROLLER. NO SYMPTOMS WERE REPORTED. A REPLACEMENT REQUEST HAS BEEN PROCESSED.

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

  MAUDE report 10453606 ↗
• MalfunctionAug 31, 2018Communication or Transmission Problem; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. PATIENT REPORTED GETTING POOR COMMUNICATION WITH THE ANTENNA. PRIOR TO THE REPORT, PATIENT TRIED WITHOUT THE ANTENNA. IT WAS REVIEWED FOR PATIENT TO PLACE THE PATIENT PROGRAMMER (PP) DIRECTLY OVER THE INS AND SYNC WITH THE INS, AND THIS RESOLVED THE POOR COMMUNICATION. THE PP ANTENNA IS REPORTED TO BE DAMAGED. IT WAS NOTED THAT THE PATIENT USES THE ANTENNA. NO PATIENT SYMPTOMS WERE REPORTED. A REPLACEMENT PP ANTENNA WAS SENT TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7836705 ↗
• MalfunctionJan 3, 2018Failure to Interrogate; Device Displays Incorrect Message; Communication or Transmission Problem; Device Operates Differently Than Expected; Failure to Interrogate; Device Displays Incorrect Message; Communication or Transmission Problem; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM THE CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THERE WAS POOR COMMUNICATION ON/WITH THE PROGRAMMER UNIT. THE PATIENT STATED THAT IT APPEARED THE PROGRAMMER ANTENNA WAS NOT WORKING ANYMORE BECAUSE THEY COULD NOT CONNECT TO THEIR INS WHILE USING THE PROGRAMMER WITH THE ANTENNA PLUGGED IN. THERE WAS NO TELEMETRY WITH THE ANTENNA ATTACHED. THE PATIENT STATED THEY COULD CONNECT JUST FINE WHEN THE ANTENNA WAS DISCONNECTED. NO PATIENT SYMPTOMS OR HARM WERE REPORTED IN THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7162342 ↗
• MalfunctionSep 1, 2017Failure to Interrogate; Communication or Transmission Problem; Device Operates Differently Than Expected; Failure to Interrogate; Communication or Transmission Problem; Device Operates Differently Than Expected

  INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMOR AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT COULD NOT DO TELEMETRY WITH THEIR ANTENNA ON THEIR PATIENT PROGRAMMER. THE PATIENT PROGRAMMER COULD DO TELEMETRY WITHOUT THE ANTENNA, HOWEVER. 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 6839327 ↗
• MalfunctionJun 21, 2017Failure to Interrogate; Communication or Transmission Problem; Failure to Interrogate; Communication or Transmission Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL AND CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT PROGRAMMER WAS NOT WORKING. THE PATIENT ORIGINALLY CALLED AND REPORTED THAT THE DEVICE HAD STOPPED WORKING AND INDICATED THEY WOULD TRY TO REPLACE THE BATTERIES. THE HEALTHCARE PROVIDER CALLED BACK A COUPLE DAYS LATER AND CONFIRMED A "POOR COMMUNICATION" SCREEN ON THE PATIENT PROGRAMMER. THE ISSUE WAS RESOLVED WHEN THE CALLER UNPLUGGED THE ANTENNA AND TRIED TO COMMUNICATE WITH THE DEVICE. 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 6658625 ↗
• 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 HAD BEEN GETTING POOR COMMUNICATION WITH THEIR PATIENT PROGRAMMERS FOR THE PAST SEVERAL MONTHS. A COUPLE MONTHS AGO THE PATIENT PROGRAMMER COMPLETELY STOPPED WORKING WITH AND WITHOUT THE ANTENNA, AND WOULD NOT DO TELEMETRY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6610807 ↗

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.