NA 37022 (UDI 00643169974807)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169974807), received between Apr 18, 2022 and Sep 6, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High impedance” (4 reports).

20 other recalls cover devices cleared under the same FDA submission (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 6, 2023High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT THE PATIENT WAS IN THE OPERATING ROOM GETTING BILATERAL SENSIGHT LEAD PLACEMENT. ONE SIDE OF BRAIN WAS COMPLETED FINE BEFORE CALL BUT AT THE TIME OF THE CALL, THE OTHER SIDE OF THE BRAIN WAS PROVIDING RED IMPEDANCE ALL WITH 1. THEY WERE ON THEIR 2ND LEAD FOR THIS SIDE, REPLACED TEST CABLE, TABLET, COMMUNICATOR, AND EXTERNAL NEUROSTIMULATOR (ENS). CALLER STIMMED SHORT- MAYBE 60 SECONDS- CONTACT 1 WITH 2ND LEAD AND VALUES MOVED FROM HIGH TO 10300 ON 1C. CONFIRMED LEAD ON OTHER SIDE WORKING FINE WITH CURRENT EQUIPMENT. BACK TO SECOND SIDE AND DECIDED TO TRY A 3RD LEAD AND ALL PAIRING WERE GREEN AND THE PLACEMENT WAS FINISHED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP)THAT TWO LEADS WERE OPENED AND TESTED BUT NEITHER WERE IMPLANTED. STIMULATION WAS USED TO CLEAR THE IMPEDANCE. THE DEVICE WILL NOT BE RETURNED AS THE PHYSICIAN WOULD LIKE TO PERFORM THEIR OWN TESTING. THE IMPEDANCE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17689414 ↗
• MalfunctionJun 21, 2023High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED IT WAS AN ALPHA OMEGA LEAD CANNULA, BUT THE SIZE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170101 ↗
• MalfunctionOct 11, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE (REP) THAT THEY WERE IN A STAGE 1 LEAD IMPLANT AND THERE WAS HIGH IMPEDANCE OF 21K OHMS ON CONTACT 2B WHEN THEY TESTED THE LEAD WITH THE EXTERNAL NEUROSTIMULATOR (ENS). THE REP REPORTS THERE WAS A CHARGE DENSITY WARNING ON CONTACT 1 WHEN THEY TRIED TO STIMULATE IN RING MODE WITH THE ENS. THE REP SAID THE IMPEDANCES OF EACH RING ON THE 1 CONTACT WERE ALL AROUND 3100-3200 OHMS. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15579799 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMATOMA WHERE THE RIGHT LINGUAL VEIN WAS NICKED DURING INTRODUCER PLACEMENT RESULTING IN HEMATOMA ON THE FLOOR OF THE MOUTH AND THE STUDY WAS HALTED EARLY. THE PATIENT WAS ADMITTED TO THE ICU FOR TONGUE EDEMA. PATIENT WAS EXTUBATED FOR 4 HOURS WHILE BEING IN THE ICU. PATIENT WAS THEN ADMITTED FOR OBSERVATION OVERNIGHT AND SUBSEQUENTLY DISCHARGED THE NEXT MORNING. THE PATIENT ALSO EXPERIENCED A SORE TONGUE AND AREA UNDER THE CHIN. ACTION TAKEN INCLUDED PERIDEX MOUTH WASH. THE PATIENT ALSO EXPERIENCED CHEST PAIN AFTER THEY COUGH. IT WAS LIKELY THAT THE TRAUMA FROM THE INTUBATION CAUSED THE CHEST PAIN. IT WAS STATED THE ISSUE RESOLVED ON (B)(6) 2022 AND THE SEVERITY WAS MODERATE. THE SORE THROAT ALSO RESOLVED ON (B)(6) 2022 WITH A MILD SEVERITY. FURTHERMORE, THEY EXPERIENCED NECK SWELLING WITH SLIGHT PAIN, BRUISING, AND SWELLING AT SITE OF INSERTION FROM THE PROCEDURE. PRIMARY INDICATION FOR DISE PROCEDURE: EPIGLOTTIS SURGERY, EVALUATION FOR HGN STIMULATION IMPLANT.

  Patient problems: Bruise/Contusion; Chest Pain; Discomfort; Hematoma; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 15330161 ↗
• InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED HEMATOMA WHERE THE RIGHT LINGUAL VEIN WAS NICKED DURING INTRODUCER PLACEMENT RESULTING IN HEMATOMA ON THE FLOOR OF THE MOUTH AND THE STUDY WAS HALTED EARLY. THE PATIENT WAS ADMITTED TO THE ICU FOR TONGUE EDEMA. PATIENT WAS EXTUBATED FOR 4 HOURS WHILE BEING IN THE ICU. PATIENT WAS THEN ADMITTED FOR OBSERVATION OVERNIGHT AND SUBSEQUENTLY DISCHARGED THE NEXT MORNING. THE PATIENT ALSO EXPERIENCED A SORE TONGUE AND AREA UNDER THE CHIN. ACTION TAKEN INCLUDED PERIDEX MOUTH WASH. THE PATIENT ALSO EXPERIENCED CHEST PAIN AFTER THEY COUGH. IT WAS LIKELY THAT THE TRAUMA FROM THE INTUBATION CAUSED THE CHEST PAIN. IT WAS STATED THE ISSUE RESOLVED ON (B)(6) 2022 AND THE SEVERITY WAS MODERATE. THE SORE THROAT ALSO RESOLVED ON (B)(6) 2022 WITH A MILD SEVERITY. FURTHERMORE, THEY EXPERIENCED NECK SWELLING WITH SLIGHT PAIN, BRUISING, AND SWELLING AT SITE OF INSERTION FROM THE PROCEDURE. PRIMARY INDICATION FOR DISE PROCEDURE: EPIGLOTTIS SURGERY, EVALUATION FOR HGN STIMULATION IMPLANT.

  Patient problems: Bruise/Contusion; Chest Pain; Discomfort; Hematoma; Pain; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 15330121 ↗
• MalfunctionApr 18, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE CALLER WAS IN OPERATING ROOM WITH STAGE 1, USING B33015M42 LEAD AND TEST CABLE, B31050. CALLER REPORTED HE WAS UNABLE TO PASS THE LEAD CONNECTIVITY TEST. THE CALLER REPORTED HE HAS SWITCHED OUT TWO DIFFERENT MARKED SENSIGHT LEADS, ENS AND TEST CABLE, AND CONTINUED TO SEE HIGH IMPEDANCE. CALLER REPORTED HE HAS DONE A FULL IMPEDANCE TEST X6, SETSCREW NOT OVERLY TIGHTENED, CAN SEE THE MARKER OF THE LEADS ON THE WINDOW. CALLER REPORTED HE TRIED REMOVING AND RE-INSERTING THE STYLE, DID NOT RESOLVE. THE CALLER ADDED THAT IN ADDITION TO REPLACING THE LEAD, ENS AND CABLE, THEY ALSO TRIED 2 TABLETS. CALLER STATED RUNNING ELECTRODE IMPEDANCES AT 3.0V, SHOWED ALL MONOPOLAR PAIRS WERE RED AND ALL BIPOLAR PAIRS WERE RED OR ORANGE EXCEPT FOR 0-2B, 1B-2B, 1C-2B, 0-1B, 1B-1C PAIRS. THE CALLER STATED THEY RAN STIM THROUGH LEAD ALREADY AS WELL. TECHNICAL SERVICES SPECIALIST (TSS) SUGGESTED SETTING UP SIMPLE PROGRAM ON BIPOLAR PAIR WITH HIGH IMPEDANCE AND RUNNING THERAPY IMPEDANCE. WHILE ON THE CALL, HCP WAS ANCHORING LEAD AS THEY BELIEVED THERE WAS AN ISSUE WITH THE MEASUREMENT RESULTS AND WAS GOING TO MOVE FORWARD WITH CURRENT LEAD. CALLER ASKED IF ALLIGATOR CLIPS COULD BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14138595 ↗

Recalls under the same FDA submission

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

• 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-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-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.