ACTIVA® SC 37603 (UDI 00613994761088)Recalls & reported problems

Summary

The FDA's MAUDE database contains 330 adverse event reports that list this exact device (DI 00613994761088), received between May 1, 2017 and Mar 25, 2026 — classified as 1 death, 141 injuries, 188 malfunctions.

The most frequently reported specific device problem is “Energy Output Problem” (48 reports).

20 other recalls cover devices cleared under the same FDA submission (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 25 most recent of 330 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM PATIENT INDICATING THAT ONCE THEIR BATTERY WAS REPLACED IT NEVER WORKED RIGHT AGAIN. THEY ATTEMPTED RESETS BUT FUNCTION REMAINED POOR SO THEY OPTED TO LEAVE IT OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690150 ↗
• MalfunctionJul 7, 2025Electrostatic Discharge; Electrostatic Discharge

  ADDITIONAL INFORMATION WAS PROVIDED. THE CALLER REITERATED PREVIOUSLY NOTED EVENTS AND REQUESTED THAT A REPRESENTATIVE VISIT THEIR HOME TO CHECK THE IMPLANT, AS THE ISSUE HAS NOT BEEN RESOLVED. THE AGENT REVIEWED THE ROLE OF THE REPRESENTATIVE AND SUBSEQUENTLY FOLLOWED UP WITH THE REPRESENTATIVE, REQUESTING THAT THEY REACH OUT TO THE CALLER REGARDING THE ISSUE.

  Patient problems: Shaking/Tremors

  MAUDE report 22420914 ↗
• InjuryMay 27, 2025Battery Problem; Battery Problem

  ON 2025-MAY-05 (B)(4) (CON): INFORMATION WAS RECIEVED FROM A PATIENT REGARDING AND IMPLANTABLE DEVICE. PATIENT REPORTED THAT THEY WERE TOLD THEIR FIRST DEVICE WAS SUPPOSED TO LAST 10 YEARS BUT IT ONLY LASTED 4 YEARS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087323 ↗
• InjuryMar 20, 2025Battery Problem; Battery Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT. PATIENT REPORTED THAT THEY HAD TO SET UP AN APPOINTMENT WITH SURGEON FOR A NEW BATTERY TO RESOLVE ISSUE. PATIENT REPORTED THAT SWITCHING TO A RECHARGEABLE NEUROSTIMULATOR RESOLVED ISSUE OF BATTERIES GOING TOO QUICK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21658766 ↗
• MalfunctionMar 7, 2025Unstable; Communication or Transmission Problem; Insufficient Device Problem Information; Unstable; Communication or Transmission Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A CONSUMER WHO REPORTED RECHARGING DIFFICULTIES DUE TO THE PATIENT¿S PROGRESSING PARKINSONS THEY ALSO HAVE DYSTONIA PROBLEMS WHERE THEIR TOES ARE BENT, AND THEY CANNOT UNBEND THEM. IT WAS MENTIONED WHEN THE PATIENT IS TIRED THEIR LEFT SIDE SHOULDER SLOPES DOWN AND IS NOT LEVEL, SO THE LEFT SIDE WAS DIFFICULT TO CHARGE RESULTING IN ONLY GETTING A GOOD CONNECTION SOMETIMES WITH RECEIVING A MESSAGE ABOUT THIS RESULTING IN IT TAKING A LONGER TIME TO CONNECT, THE RIGHT CHEST STIMULATOR CHARGES FINE. THE PATIENT MET WITH A MANUFACTURER¿S REPRESENTATIVE (REP) WHO CONFIRMED A GOOD CONNECTION WITH THEIR EQUIPMENT AND REVIEWED SOME BEST RECHARGING PRACTICES. THE CONSUMER SAID FOLLOWING A HEALTH ISSUE THE STAFF AT THE HCP OFFICE TOLD THEM, SOMETHING HAPPENED DURING THE INCIDENT THAT CAUSED THEIR DBS TO TAKE "A HIT" AND CAUSED THEIR DYSTONIA (TOES/ SHOULDER SYMPTOMS). THE STAFF MEMBER SAID THE LEFT SIDE HAS AN IMPINGEMENT ON A NODE BUT IT'S OK BECAUSE IT IS A NODE THAT IS NOT NEEDED. THE CONSUMER MENTIONED SOMETIMES THE PATIENT¿S ¿BRAIN DISCONNECTS¿ BECAUSE OF THEIR PARKINSON¿S.

  Patient problems: Insufficient Information; Unspecified Nervous System Problem

  MAUDE report 21547216 ↗
• InjuryJan 27, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE EXTENSION WAS NOT REPLACED WITH NO PLANS TO REPLACE THE EXTENSION. THE IMPEDANCE ISSUE DID NOT RESOLVE AFTER THE NEUROSTIMULATOR WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21248868 ↗
• MalfunctionJan 22, 2025High impedance; Low impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Low impedance; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE BATTERY WAS REPLACED DUE TO NORMAL BATTERY DEPLETION. THE CAUSE OF THE LOW AND HIGH IMPEDANCES WASN¿T DETERMINED AS THE ISSUE WASN¿T RESOLVED EVEN AFTER DISCONNECTING AND RECONNECTING THE LEAD INTO THE NEW NEUROSTIMULATOR AND SEVERAL IMPEDANCE CHECKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21209067 ↗
• MalfunctionMay 8, 2024Failure to Deliver Energy; Failure to Deliver Energy

  ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE CIRCUMSTANCES THAT LED TO THERAPY BEING OFF WAS THEM INADVERTENTLY TU RNING OFF THE DEVICE WHILE STARTING IT. THE PATIENT WAS GIVEN INSTRUCTIONS ON HOW TO USE THE DEVICE. THE ISSUE WAS RESOLVED.

  Patient problems: Shaking/Tremors

  MAUDE report 19268414 ↗
• MalfunctionJan 31, 2024Mechanical Problem; Failure to Power Up; Insufficient Device Problem Information; Mechanical Problem; Failure to Power Up; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT PUT NEW BATTERIES IN THE PATIENT PROGRAMMER BUT THEY WERE GETTING "MEDTRONIC 2.1" ON THE SCREEN AND COULDN'T GET TO THE NORMAL SYNC SCREEN. THE PATIENT PUT IN ANOTHER SET OF AAA BATTERIES AND THE 'CALL YOUR DR. 006" MESSAGE APPEARED. PS (PATIENT SERVICES) REVIEWED THIS MEANT THERE COULD BE A STUCK KEY ON THE PATIENT PROGRAMMER. THE PATIENT PRESSED ALL KEYS ON PATIENT PROGRAMMER AND THEN POWERED OFF PATIENT PROGRAMMER, PATIENT PROGRAMMER THEN WOULDN'T POWER BACK ON. THE ISSUE WAS NOT RESOLVED. AN EMAIL WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE PATIENT PROGRAMMER. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18619781 ↗
• MalfunctionJan 31, 2024Corroded; Display or Visual Feedback Problem; Failure to Power Up; Battery Problem; Corroded; Display or Visual Feedback Problem; Failure to Power Up; Battery Problem

  IT WAS REPORTED THAT PATIENT HAD NOT USED THEIR PATIENT PROGRAMMER IN SEVERAL MONTHS, AND WHEN THEY WENT TO USE IT, THE BATTERY WAS DEAD. THE CALLER CHANGED OUT THE BATTERIES AND THE PROGRAMMER WOULD NOT TURN ON. THE PATIENT STATED THAT OUT OF FRUSTRATION, THEY HAD PRESSED SEVERAL DIFFERENT BUTTONS. THE CALLER THEN REPORTED SEEING A SCREEN ON THE PROGRAMMER SAYING "SYSTEM SET UP" WITH OPTIONS OF SELECT OR EXIT. PATIENT SERVICES (PSS) REVIEWED MEANING OF THIS SCREEN AND EXPLAINED THAT THE PROGRAMMER WOULD HAVE TO BE REPLACED. DURING THE CALL, THE CALLER NOTICED ACID BUILD UP IN THE BATTERY COMPARTMENT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18612903 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT PATIENT PROGRAMMER WOULD NOT POWER ON. THE PATIENT STATED THAT THEY REPLACED THE AAA BATTERIES IN THE PATIENT PROGRAMMER, BUT THE ISSUE PERSISTED. THE PATIENT CONFIRMED THEY WERE USING ALKALINE BATTERIES. THE PATIENT DENIED DROPPING THE PATIENT PROGRAMMER OR GETTING IT WET. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED AS THE PATIENT DID NOT HAVE THE PATIENT PROGRAMMER WITH THEM. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607116 ↗
• MalfunctionJan 30, 2024Failure to Power Up; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER WOULD NOT POWER ON. THEY STATED THEY WERE UNABLE TO TURN THERAPY ON/OFF AS NEEDED. THEY REPLACED THE DEVICE BUT IT STILL WOULDN'T POWER ON. THE ISSUE WAS NOT RESOLVED. A REPLACEMENT WAS SENT. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606666 ↗
• MalfunctionJan 29, 2024Failure to Power Up; Audible Prompt/Feedback Problem; Failure to Power Up; Audible Prompt/Feedback Problem

  IT WAS REPORTED THAT THE PATIENT PLACED NEW BATTERIES INTO THE PATIENT PROGRAMMER (PP) TODAY AND THE PP WILL NOT TURN ON. THE CALLER STATED SHE PLACED ENERGIZER INDUSTRIAL BATTERIES IN THE PP. TECHNICAL SERVICES SPECIALIST (TSS) REVIEWED THAT THOSE BATTERIES CAN PROVIDE COMPLICATIONS FOR USE OF THE PP. TSS ADVISED CALLER TO GET NORMAL ALKALINE BATTERIES. THE CALLER CONFIRMED THE NEW BATTERIES DID NOT RESOLVE THE ISSUE. THE PP DID BEEP WHEN BATTERIES WERE INSERTED, BUT NO DISPLAY. THE PP DID NOT GET WET. A REPLACEMENT PROGRAMMER WAS SENT OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18599035 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CALLER INDICATED PATIENT WAS ADMITTED TODAY FOR MENTAL STATUS CHANGE. CALLER WASN'T ABLE TO PROVIDE FURTHER DETAIL ON THE MENTAL STATUS CHANGE.

  Patient problems: Cognitive Changes

  MAUDE report 18538579 ↗
• InjuryJan 9, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED THAT PATIENT (PT) STATED 37642 PROGRAMMER IS SHOWING PICTURES OF IMPLANTED NEUROSTIMULATOR AND NOT WORDS. PATIENT STATES HE IS IN THE HOSPITAL AND NEEDS TO HAVE AN MRI AND IS TRYING TO TURN OFF THERAPY. PATIENT SERVICE SPECIALIST INSTRUCTED PATIENT HOW TO CHANGE FROM ICON MODE TO TEXT MODE. PATIENT WAS THEN ABLE TO SEE THERAPY WAS OFF. PATIENT WAS ALSO ABLE TO TURN OFF OTHER IMPLANTABLE NEUROSTIMULATOR (INS). NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18477464 ↗
• InjuryDec 1, 2023Battery Problem; Insufficient Device Problem Information; Battery Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT FROM HEALTHCARE PROVIDER (HCP) HE WAS INFORMED BY PATIENT (PT) FAMILY MEMBER THAT THE DBS AND CONTROLLER WERE REPLACED IN (B)(6) 2023. CALLER REPORTS THEY SAID THE DBS WAS REPLACED AS THE BATTERY WAS NOT WORKING ANYMORE. CALLER HAD NO ADDITIONAL DETAIL TO PROVIDE. NO SYMPTOMS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18246104 ↗
• MalfunctionOct 31, 2023High impedance; High impedance

  IT WAS REPORTED THAT CALLER HAD SEEN THE PATIENT YESTERDAY FOR NORMAL CHECK IN AND NOTED THE IMPEDANCES WERE A LITTLE ELEVATED ON THE LEFT SIDE 0/2 5337, 0/3 5471M C/0 5139 BUT 0/1 WERE NORMAL AND THAT IS WHAT THEY WERE PROGRAMMED ON. IMPEDANCES FROM 6 MONTHS AGO WERE NORMAL. REVIEWED CONSIDERATIONS AND SINCE THE PATIENT IS GETTING GREAT THERAPY THEY WILL BE KEEPING AN EYE ON IT. PATIENT IS AT 2.68V BATTERY LEVEL SO WHEN THEY GO TO REPLACEMENT SHE WILL SUGGEST CHECKING THE COMPONENTS. NO SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THEY WERE WITH THE PATIENT TODAY AND A IMPEDANCE CHECK AT 3 VOLTS SHOWED INVESTIGATE FOR ELECTRODE 0 WITH RESULTS OF >4,000 OHMS. PATIENT WAS IN GROUP B WITH 0+ AND -1 AT 90USEC. IT WAS REVIEWED THAT GIVEN THE IMPEDANCE WAS HIGH THEY MAY NOT WANT TO USE ELECTRODE 0 AND TO TRY C1 OR 1- AND 2+ COUPLED WITH PULSE WIDTH AND RATE ADJUSTMENT TO SEE IF THE PATIENT WOULD GET RELIEF. THE HCP DECIDED TO MAKE A NEW GROUP. THE CAUSE OF THE HIGH IMPEDANCE WAS UNKNOWN AND NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18037527 ↗
• InjuryJul 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PREVIOUS IMPLANTABLE NEUROSTIMULATORS WENT WRONG. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278482 ↗
• InjuryJul 7, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED, THAT THE PREVIOUS IMPLANTABLE NEUROSTIMULATORS WENT WRONG. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17278187 ↗
• InjuryApr 20, 2023Break; Unintended Collision; Adverse Event Without Identified Device or Use Problem; Break; Unintended Collision; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INCAPACITATED, PATIENT HAD A SEIZURE. NO FURTHER DETAIL SINCE THIS WAS FROM INTAKE NURSE. THE CALLER WAS NOT WITH THE PATIENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER (HCP) TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE CAUSE OF THE SEIZURES AND INCAPACITATION WAS DUE TO FALLS WITH A HEAD INJURY AND BILATERAL HYGROMAS IN ADDITION TO DAMAGING/FRACTURING THE LEADS AS A RESULT OF THE TRAUMA. AS A RESULT, THE PATIENT WAS PRESCRIBED SEIZURE MEDICATION AND THEY HAD THEIR DBS SYSTEM REMOVED WITH A RETAINED LEAD TIP. THE PATIENT¿S HCP WAS GOING TO DISCUSS WITH THE NEUROSURGEON WHAT TO DO WITH THE RETAINED LEAD TIP AND WHETHER REIMPLANTATION WAS AN OPTION.

  Patient problems: Convulsion/Seizure; Device Embedded In Tissue or Plaque; Fall; Insufficient Information

  MAUDE report 16775839 ↗
• InjuryApr 10, 2023Break; Low impedance; Break; Low impedance

  IT WAS REPORTED THAT DURING THE EXTENSION REPLACEMENT, THE HEALTHCARE PROVIDER (HCP) NOTICED THE EXTENSION/LEAD CONNECTION HAD NOT INSULATION, THUS HCP EXPLANTED THE LEAD BUT ONE OF THE DISTAL ELECTRODE IS STUCK IN THE BRAIN(RIGHT). ON THE LEFT SIDE THE IMPEDANCE FOR ELECTRODE 2<(>&<)>3 HAD A SHORT AND HCP DECIDED TO REMOVE THE LEAD AS WELL, AND HCP NOTED THE LEAD DIDN'T HAVE INSULATION ABOVE WHERE IT CONNECTED TO THE EXTENSION. AT THIS POINT HCP IS GOING TO REMOVE EVERYTHING. HCP WILL DECIDE IF THE DISTAL CONTACT STUCK IN THE BRAIN CAN BE REMOVED. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16709311 ↗
• InjuryMar 15, 2023Unintended Collision; Therapy Delivered to Incorrect Body Area; Unintended Collision; Therapy Delivered to Incorrect Body Area

  INFORMATION WAS RECEIVED FROM A PATIENT'S REPRESENTATIVE REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REP WAS CALLING FOR INFORMATION IN REGARDS TO PATIENT NEEDING A MRI. CALLER STATED WITHIN THE LAST MONTH PATIENT'S PARKINSON'S HAS GOTTEN WORSE AND HAS BEEN FALLING MORE FREQUENTLY. THE MOST RECENT FALL WAS ON SATURDAY WHICH LANDED THE PATIENT IN THE HOSPITAL. CALLER STATES THE PATIENT HIT HER HEAD IN TWO DIFFERENT TIMES AND ALSO MAY HAVE BROKEN THEIR SHOULDER , HENCE WHY HOSPITAL WANTS TO DO A MRI. CALLER STATES THAT THEY ARE UNSURE IF THE FALL IS RELATED TO THE DBS OR MEDICATION. CALLER ALSO REPORTS WITHIN THE LAST 24 HOURS THE PATIENT HAS HAD 4 EPISODES OF INTENSE PAIN IN HER HEAD. CALLER REPORTS THE PATIENT FEELS AN ELECTRICAL IMPULSE ABOVE THEIR LEFT EAR AND DOES FEEL LIKE THIS PAIN IS RELATED TO DBS. PATIENT SERVICES (PSS) REVIEWED MRI GUIDELINES AND DIRECTED CALLER TO REACH OUT TO MANAGING HEALTHCARE PROVIDER (HCP) TO ADDRESS THE CONCERNS AND ISSUES FURTHER.

  Patient problems: Bone Fracture(s); Fall; Pain

  MAUDE report 16546074 ↗
• MalfunctionMar 7, 2023Failure to Deliver Energy; Migration or Expulsion of Device; Insufficient Device Problem Information; Failure to Deliver Energy; Migration or Expulsion of Device; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THE CAUSE OF THE IMPLANT MOVING WAS NOT DUE TO WEIGHT LOSS AND WASN¿T DETERMINED; THE GENERATOR IN THE LEFT CHEST SHIFTS, BUT IT COULD BE FOUND WITH SOME EFFORT. THERE WERE NO PLANS TO RESOLVE THE ISSUE AS THE IMPLANT WAS WORKING, IT JUST TOOK SOME ¿EFFORT¿ TO FIND IT. THE HCP WAS GOING TO WAIT FOR REPLACEMENT UNTIL THE BATTERY WAS APPROPRIATELY DEPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16498519 ↗
• MalfunctionFeb 9, 2023High impedance; High impedance

  INFORMATION WAS RECEIVED FROM A MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH A HEALTHCARE PROVIDER (HCP), WHO REPORTED DURING BATTERY REPLACEMENT DUE TO REACHING ERI IT WAS NOTED THE PATIENT HAD OUT OF RANGE IMPEDANCES ON BOTH LEADS ON THE LEFT SIDE (NO VALUES WERE DOCUMENTED). THE DEVICE WAS REPROGRAMMED USING C+2-TO AVOID USING THE OUT-OF-RANGE IMPEDANCES ON BIPOLAR PAIRS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16334843 ↗
• MalfunctionFeb 8, 2023Electromagnetic Interference; Overheating of Device; Electromagnetic Interference; Overheating of Device

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BRIEF SENSATION OF WARMTH ON THE RIGHT SIDE OF THEIR HEAD/FACE WHILE THEY WERE GETTING AN MRI OF THEIR WRIST. THE PATIENT ADDED THAT THEY FELT THE WARMTH "WHERE THE IMPLANT IS CAPPED ON THE RIGHT SIDE; THERE IS A BUMP THERE ON THE FOREHEAD CLOSE TO THE HAIRLINE." THE PATIENT DESCRIBED THE SENSATION AS A "HOTTER FEELING - MORE WARM AT FIRST, THEN IT GRADUALLY EASED OFF." THE PATIENT NOTED THAT THE SENSATION ONLY LASTED 5-10 SECONDS. WHEN THE PATIENT BEGAN TO FEEL THE WARMTH, THEY TOLD THE MRI TECHNICIAN AND THEY STOPPED THE MRI. THE MRI TECHNICIAN SPOKE WITH THE PATIENT TO MAKE SURE THEY WERE OKAY, THEN THEY PROCEEDED WITH THE MRI. THE PATIENT SAID THEY NEVER FELT THE SENSATION OF WARMTH FOR THE REMAINDER OF THE MRI. THE PATIENT SAID THEY REPORTED THIS ISSUE TO THEIR NEUROLOGIST, WHO THEN TOLD THE PATIENT TO REPORT IT TO THE MANUFACTURER. AGENT REVIEWED INFORMATION FROM LABELING REGARDING SENSATION OF HEAT DURING MRI. THE PATIENT'S HUSBAND WAS ALSO ON THE LINE, WHO STATED THAT THE PATIENT HAD MET WITH THEIR NEUROLOGIST PRIOR TO THE MRI, NOTING THAT THE NEUROLOGIST DID AN IMPEDANCE CHECK AND COMPLETED THE MRI ELIGIBILITY REPORT, WHICH WA

  Patient problems: Burning Sensation

  MAUDE report 16327131 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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.