NA 37022 (UDI 00613994972286)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00613994972286), received between Jun 12, 2017 and Aug 22, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “High impedance” (5 reports).

28 other recalls cover devices cleared under the same FDA submission (H020007, H050003, P840001, 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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE LEAD WAS INSERTED AND TESTING CABLE WAS CONNECTED. WHILE RUNNING THE VERIFICATION TEST, THE RESIDENT CONNECTED THE MONOPOLAR CABLE TO THE LEAD TEST CABLE JUST AS THE VERIFICATION PROCESS WAS BEING COMPLETED SO IT CAME BACK AS UNABLE TO VERIFY. THE MANUFACTURER'S REPRESENTATIVE (REP) RESET THE CONFIGURATION TO INCLUDE THE MONOPOLAR TEST CABLE AND RAN THE TEST AGAIN AND IT CONTINUED TO BE UNVERIFIED. THE REP RAN AN IMPEDANCE TEST AND ALMOST ALL CONTACTS WERE SHOWING RED. CONTACT 1 WAS THE ONLY ONE THAT HAD SOME YELLOW. IT WAS REPORTED THE ISSUE COULD POSSIBLY BE RELATED TO THE DBS APP, SINCE IT STARTED WORKING AFTER RESTARTING THE APP. THE CABLE WAS DISCONNECTED AND RECONNECTED AND TRIED SOME HALF TURNS BUT THE ERROR REMAINED. AFTER TRYING THIS A COUPLE OF TIMES, THEY TRIED A NEW TESTING CABLE BUT GOT THE SAME RESULT. SO, A NEW LEAD WAS THEN OPENED AND AGAIN GOT THE SAME RESULT. THE REP RECHECKED THE LEAD CONFIGURATION SET UP AND IT WAS ALL CORRECT. AT THIS POINT, THE DBS APP WAS CLOSED DOWN AND RESTARTED A NEW ENS CONNECTION. WHEN THE REP RERAN THE VERIFICATION, IT CAME BACK OK AND IMPEDANCES WERE NORMAL. THE ISSUE WAS RESOLVED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034250 ↗
• MalfunctionJan 20, 2023High impedance; High impedance

  IT WAS REPORTED THAT DURING THE TESTING LEAD FOR THE STAGE 1 PORTION, ALL OF THE IMPEDANCES ON CONTACT 1 WERE OUT OF RANGE ON THE HIGH SIDE. NO ENVIRONMENTAL FACTORS MAY HAVE LED TO OR CONTRIBUTED TO THE ISSUE. THE PHYSICIAN TRIED TO DETACH AND REATTACH THE TESTING CABLE. THAT DIDN'T WORK. A SECOND TESTING CABLE WAS DROPPED AND ALSO SHOWED THAT THE IMPEDANCES WERE HIGH AND OUT OF RANGE. THE PHYSICIAN ASKED FOR A NEW LEAD FOR THE RIGHT SIDE. THE SAME HAPPENED FOR THE LEFT HEMISPHERE LEAD THAT WAS DISCARDED. AGAIN, IMPEDANCES WERE OUT OF RANGE. THE PHYSICIAN CHECKED CONNECTIONS, AND THE IMPEDANCES WERE STILL OUT OF RANGE EVEN AFTER THE NEW LEAD WAS GIVEN TO HIM. AT THAT POINT, THE PHYSICIAN REMOVED THE TESTING CABLE, CLEANED THE CONNECTOR PIN PORTION OF THE LEAD WITH A WET 4X4, AND RECHECKED IMPEDANCES. THE IMPEDANCES WERE WITHIN THE NORMAL OPERATING RANGE. THE TROUBLESHOOTING STEPS THAT WERE TAKEN RESOLVED THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16219361 ↗
• MalfunctionMar 28, 2022High impedance; High impedance

  IT WAS REPORTED THAT THERE WAS AN IMPEDANCE INCREASE IN LEAD (0 ELECTRODE), RESULTING IN OPEN CIRCUIT IN TEST IMPEDANCE INTRA-OP. IT DID NOT CHANGE WHEN THEY CLEANED THE ELECTRODE AND VISUAL INSPECTION DID NOT SHOW DAMAGE. THERE WERE NO FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE LEAD WAS REPLACED AND THE ISSUE WAS RESOLVED. THERE WAS NO INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13931734 ↗
• MalfunctionMar 17, 2022High impedance; High impedance

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13794013 ↗
• InjuryFeb 21, 2022High impedance; High impedance

  IT WAS REPORTED THAT DURING STAGE 1 LEAD IMPLANT, REPORTED ONE SIDE TESTED GOOD, BURIED LEAD AND WENT TO THE OTHER SIDE IMPLANTED LEAD AND FOUND SEGMENT 2A AND 2B >30,000 OHMS. AN ATTEMPT WAS MADE TO RESOLVE THE ISSUE, BY REPLACING TABLET, ENS, CABLE AND THEN LEAD. CALLER REACHED OUT TO TSS AFTER LEAD REPLACEMENT, AND NOW 2B AND 2C ARE >30,000 OHMS. IT WAS DECIDED TO IMPLANT LEAD AND CHECK IMPEDANCES WHEN INS IS CONNECTED. CALLER NEEDED TO DISCONNECT CALL - WILL EMAIL REP TO GET REQUIRED INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THEY WERE GETTING CONFIGURATION NOT VERIFIED BUT THIS WAS RESOLVED BY RE-CLIPPING AND POSITIONING THE TEST CABLE. THE REP TESTED AT HOME WITH A NEW LEAD AND ENS SUBMERGED IN WATER AND STILL REPLICATED THE HIGH IMPEDANCES ON CONTACT 2C (>10K OHMS) EVEN AFTER LETTING VOLTAGE RAMP UP WITH IMPEDANCE CHECK. THE REP WAS USING A SENSIGHT LEAD AND HAD SWAPPED TO A DIFFERENT TABLET OWNED BY THE HCP. THEY ADDED THAT A COLLEAGUE AND HCP HAD SEEN THIS BEFORE BUT APPEARS TO RESOLVE ITSELF AFTER STAGE 2. THE REP INDICATED THAT THE CAUSE OF THE HIGH IMPEDANCE WAS NOT DETERMINED. THE HIGH IMPEDANCES ON CONTACT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573180 ↗
• MalfunctionJun 12, 2017Low impedance; Impedance Problem; Low impedance; Impedance Problem

  INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP) REGARDING A TRIAL PATIENT WITH AN EXTERNAL NEUROSTIMULATOR (ENS). THE REP REPORTED THAT THERE WAS AN OUT OF REGULATION (OOR) CODE SEEN. THE REP REPORTED THAT THEY WERE IN THE MIDDLE OF A TRIAL WITH 2 LEADS AND SEEING OOR ON TWO DIFFERENT ENS¿S. THE REP REPORTED THAT THEY WERE USING EVOLVE PROGRAMMING (90 PULSEWIDTH, 1,000 RATE) AND WHEN THEY INCREASED TO 3.4V THEY SAW OOR. THE REP REPORTED THAT ALL IMPEDANCES WERE IN RANGE AND EVERYTHING APPEARED TO BE CONNECTED. THE REP REPORTED THAT THEY CHANGED THE BATTERIES IN THE ENS BUT STILL SAW OOR BEFORE THEY PROGRAMMED ANYTHING. THE REP REPORTED THAT THE PATIENT WAS SORE ON THEIR LEFT SIDE. THE REP REPORTED THAT THEY THEN SWITCHED CLINICIAN PROGRAMMERS AND WAS ABLE TO INITIATE PROGRAMMER WITH 90 PULSEWIDTH. ONE THOUSAND (1,000) RATE ON ELECTRODES 5 AND 6 BUT AS SOON AS THEY INCREASED VOLTAGE TO 3.7V THEY SAW OOR. THE REP DECREASED RATE TO 500 AND WAS ABLE TO INCREASE TO 5V BEFORE SEEING OOR. THE REP REPORTED THAT THEY THEN WENT BACK TO 4.3V AND CHANGED RATE TO 1,000 AND WAS ABLE TO PROGRAM THIS OK. THE REP CHECKED IMPEDANCE VALUES AT 3.0V AND OUT OF RANGE VALUES WERE 4-5,

  Patient problems: Discomfort

  MAUDE report 6633161 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, H050003, P840001, 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-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-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-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• 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).

…and 13 more.