Activa® PC 37601 (UDI 00643169100770)Recalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 00643169100770), received between Dec 5, 2016 and Mar 10, 2025 — classified as 2 deaths, 57 injuries, 56 malfunctions.

The most frequently reported specific device problem is “High impedance” (27 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 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2025Display or Visual Feedback Problem; High impedance; Low impedance; Display or Visual Feedback Problem; High impedance; Low impedance

  IT WAS REPORTED THAT THE PHYSICIAN INQUIRED ABOUT AN ESTIMATE ON BATTERY LONGEVITY FOR A DBS PATIENT WITH AN ACTIVA PC. THE PHYSICIAN PLANS TO SCHEDULE A PATIENT APPOINTMENT FOR FOLLOW-UP. LONGEVITY ESTIMATIONS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) FROM IMPLANT AND SETTINGS WERE PROVIDED: GROUP A - 6 YEARS UNTIL ELECTIVE REPLACEMENT INDICATOR (ERI) AND 6.2 YEARS UNTIL END OF SERVICE (EOS), GROUP B - 7.3 YEARS UNTIL ERI AND 7.5 YEARS UNTIL EOS, GROUP C - 5.8 YEARS UNTIL ERI AND 6.0 YEARS UNTIL EOS, AND GROUP D - 6.4 YEARS UNTIL ERI AND 6.6 YEARS UNTIL EOS. IT WAS ALSO REVIEWED THAT THE IMPLANT DATE OF THE INS WAS CURRENTLY SET TO (B)(6) 2000 AND TO CONSIDER ADJUSTING THIS TO THE ACCURATE IMPLANT DATE. THERE WERE ALSO SOME OUT OF RANGE IMPEDANCE VALUES (BOTH HIGH AND LOW IMPEDANCES) ON SEVERAL CONTACTS (E.G. CONTACT 0, 1, 3, AND 4), WHICH LIKELY INDICATED THE PRESENCE OF AN INTERMITTENT INTEGRITY ISSUE. IT WAS RECOMMENDED TO AVOID THE ELECTRODES THAT HAVE OUT OF RANGE IMPEDANCES AS THIS MIGHT HAVE CONSEQUENCES ON BATTERY LONGEVITY. THE PHYSICIAN ALSO INQUIRED WHY IT TOOK SO LONG AS LAST BATTERY LIFE CHECK ON TUESDAY SHOWED 2.83V WITH LAST BATTERY REPLACEMENT ON 2017-DEC-23. IT WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21561328 ↗
• MalfunctionOct 28, 2024High impedance; High impedance

  IT WAS REPORTED BY MDT REP THAT PATIENT HAD A HIGH IMPEDANCE RESULT ON ONE EXTENSION DURING BATTERY REPLACEMENT. NO FURTHER INFO WAS PROVIDED. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20545149 ↗
• InjuryJun 1, 2024High impedance; Battery Problem; High impedance; Battery Problem

  ADDITIONAL INFORMATION RECEIVED, FROM THE MANUFACTURER¿S REPRESENTATIVE (REP). REPORTED, THE CAUSE OF THE ELEVATED IMPEDANCES WASN¿T DETERMINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19441946 ↗
• MalfunctionJan 30, 2024Corroded; Failure to Power Up; Battery Problem; Corroded; Failure to Power Up; Battery Problem

  IT WAS REPORTED THAT THE BATTERY COMPARTMENT WAS CORRODED AND THE PATIENT PROGRAMMER WON'T TURN ON. THE PATIENT COULDN'T SEE THE SERIAL NUMBER. A REPLACEMENT PROGRAMMER WAS SENT OUT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18607546 ↗
• MalfunctionJan 29, 2024Display or Visual Feedback Problem; Failure to Power Up; Display or Visual Feedback Problem; Failure to Power Up

  IT WAS REPORTED THAT THE PROGRAMMER IS NOT POWERING ON/BLANK SCREEN. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE.  THE ISSUE WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18596408 ↗
• MalfunctionNov 16, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI) AND THEY PLANNED TO REMOVE THE INS AND EXTENSION BUT LEAVE THE LEAD. THE PATIENT WANTED THE SYSTEM REMOVED DUE TO LACK OF FINANCE FOR A REPLACEMENT. THEY HAVE OPEN CIRCUIT ON THEIR LEFT GLOBUS PALLIDUS (GPI) LEAD,  MONOPOLAR CONTACT 3 - 4,158 AND BIPOLAR PAIRS 0/3 - 4,784 AND 1/3 - 4,364. THE PATIENT HAD NORMAL USE AND NO FALLING. THE IMPEDANCE ISSUE DID NOT AFFECT THE DBS THERAPY BECAUSE THEY DID NOT USE THE OPEN CIRCUIT ELECTRODE PAIR FOR PROGRAMMING. THE PATIENT WAS INFORMED THEY COULD NOT DO AN MRI.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18153029 ↗
• InjuryApr 18, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT HAD GONE THROUGH A NUMBER OF SURGERIES TO REPLACE THE DBS BATTERIES SINCE FIRST GETTING DBS, AND THAT THEY HAD BEEN TOLD THE DBS DEVICES WOULD LAST 5-7 YEARS, HOWEVER, THE PATIENT'S BATTERIES NEVER MADE IT PAST 3 YEARS, THUS HAD A LOT OF THE SURGERIES AS A RESULT. THE CALLER STATED THEY BELIEVED THIS WAS PARTLY DUE TO THE ANESTHETIC, BUT THE PATIENT WOULD TAKE 6-8 WEEKS TO RECOVER AFTER GETTING REPLACEMENTS, SO WITH PAST EXPERIENCES WITH BATTERY REPLACEMENTS, THEY COULD NOT SEE THE PATIENT GETTING ANOTHER BATTERY REPLACEMENT. REFER TO MANUFACTURER'S REPORT 3004209178-2023-05171 FOR DETAILS PERTAINING TO THE REPORTABLE RELATED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761333 ↗
• InjuryNov 1, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES AND DEVICES WERE EXPLANTED. THERE ARE NO KNOWN ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THIS EVENT. NO PATIENT SYMPTOMS WERE REPORTED. THE PATIENT WILL GET THESE DEVICES REPLACED IN THE FUTURE BY ANOTHER MEDTRONIC PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15709676 ↗
• InjuryOct 17, 2022High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT HAD HIGH IMPEDANCES ON THE RIGHT SIDE CONTACT 11. CIRCUMSTANCES THAT MAY HAVE LED/CONTRIBUTED TO THE ISSUE WERE UNKNOWN. IMPEDANCES WERE RUN IN PRE-OP AND DURING THE PROCEDURE. THE NEUROLOGY OFFICE OBSERVED THE IMPEDANCE ISSUE AND SINCE THE PATIENT NEEDED A BATTERY REPLACEMENT, THEY DECIDED TO EXPLORE THE HIGH IMPEDANCE DURING SURGERY. IMPEDANCES SHOWED THERE WAS AN OPEN/HIGH IMPEDANCES OF 30K AND HIGHER ON COMBINATIONS OF CONTACT 11 ON THE RIGHT SIDE IN PRE-OP. WHEN THE PATIENT WAS MOVED INTO THE OPERATING ROOM THE REP RAN ANOTHER IMPEDANCE TEST AND FOUND THE OPEN CLEARED BUT THERE WERE STILL HIGH IMPEDANCES AROUND 30K. SURGEON INITIALLY OPENED THE BATTERY POCKET, SWITCHED THE EXTENSIONS IN THE BATTERY, RAN ANOTHER IMPEDANCE AND THE HIGH IMPEDANCES STAYED WITH THE SAME EXTENSION. THE SURGEON THEN OPENED THE EXTENSION/LEAD CONNECTION. HE DISCONNECTED THE EXTENSION FROM THE LEAD AND CONNECTED A NEW EXTENSION (EXTERNALLY) INTO THE LEAD THEN BATTERY. THE IMPEDANCE ISSUE CLEARED UP. HE PROCEEDED TO TUNNEL TO PLACE THE NEW EXTENSION UNDER THE SKIN AND REPLACED THE BATTERY WITH A PERCEPT PC. ALL IMPEDANCE ISSUES CLEARED UP. THE SURGEON PROCEEDED TO CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614842 ↗
• MalfunctionSep 9, 2022Energy Output Problem; Device Difficult to Program or Calibrate; Energy Output Problem; Device Difficult to Program or Calibrate

  INFORMATION WAS RECEIVED FROM PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). PT HAD REPROGRAMMING YESTERDAY AND PT AWOKE WITH A HEADACHE AND PT FEELS THIS IS RELATED TO THEIR REPROGRAMMING. PT WANTS TO TURN DOWN STIMULATION. TECH SERVICES (TSS) ENDED UP WORKING WITH PT'S WIFE IN TRYING TO REDUCE AMPLITUDE. PT WAS AT 3.5 (L) AND 1.8 (R) BUT WHEN WE TRIED TO REDUCE THE SETTINGS IT INDICATED PT WAS AT LOWER LIMIT. TSS REVIEWED THAT PT COULDN'T GO ANY LOWER THAN WHERE THEIR SETTING WAS AT CURRENTLY DUE TO HOW THE LIMITS WERE SET UP. PT SAYS THEY WERE TOLD THEY WOULD BE ABLE TO CHANGE THEIR SETTINGS. TSS REVIEWED DISCUSSING FURTHER WITH THEIR HEALTHCARE PROVIDER (HCP). PT'S WIFE ALSO REVIEWED THAT PT HAD SLEEP APNEA. PT SAYS HIS TREMOR CONTROL IS THE SAME AS WHAT HE HAD PRIOR TO YESTERDAY'S REPROGRAMMING. TSS DIRECTED TO PT'S HCP FOR FURTHER QUESTIONS.

  Patient problems: Headache

  MAUDE report 15392791 ↗
• InjuryAug 23, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PAST FEW DAYS PATIENT HAD AN INFECTION AROUND THEIR DBS IMPLANT SITE. CALLER WAS ASKING FOR MRI GUIDELINES (FOR BRAIN AND CHEST MRI) AND SAID THAT THE PATIENT THOUGHT THEIR IMPLANT BATTERY WAS DEAD. THE CIRCUMSTANCES THAT LED TO THE REPORTED ISSUE WERE ASKED BUT UNKNOWN. THE ISSUE WAS NOT RESOLVED.

  Patient problems: Unspecified Infection

  MAUDE report 15278757 ↗
• InjuryAug 11, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT PATIENT REPRESENTATIVE (PT REP) REPORTED THAT PATIENT'S (PT) INS BATTERY VOLTAGE WAS AT 2.64 V ON (B)(6) 2022 AND THEN TODAY THE INS BATTERY VOLTAGE WAS AT 2.61V SHOWING ERI. PT EXPRESSED THAT THEY FELT LIKE THEIR BATTERY VOLTAGE WAS DROPPING VERY QUICKLY. PT HAS BATTERY REPLACEMENT SCHEDULED FOR (B)(6) 2022. THE ISSUE WAS NOT RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15213686 ↗
• MalfunctionAug 1, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE CALLER REPORTED THE PATIENT SAID THE GENERATOR IS NOT WORKING, CALLER WASN'T ABLE TO PROVIDE FURTHER DETAIL. CALLER WANTED TO PAGE MANUFACTURER REPRESENTATIVE (REP) FOR ASSISTANCE. THE CALLER WAS NOT WITH THE PATIENT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15142000 ↗
• InjuryMay 25, 2022Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S HASN'T BEEN RECEIVING GREAT THERAPEUTIC EFFECT SINCE LEAD WAS IMPLANTED IN 2017 DESPITE REPROGRAM MING ATTEMPTS. CALLER STATED THERE WAS NO LEAD ISSUE BUT THE HCP MEASURED THE LEAD, FELT IT WAS OFF TARGET AND THAT THEY COULD IMPROVE THE PLACEMENT. THEREFORE, TODAY, THE LEFT GPI (GLOBUS PALLIDUS) LEAD WAS COMPLETELY REMOVED AND REPLACED. IN ADDITION TO THE LEAD REPLACEMENT, ANOTHER LEAD WAS NEWLY IMPLANTED FOR THE LEFT STN (SUBTHALAMIC NUCLEUS) AS A "RESCUE LEAD" AND WILL BE CONNECTED TO AN INS AT A LATER DATE.

  Patient problems: Insufficient Information

  MAUDE report 14496270 ↗
• MalfunctionMar 25, 2022Loss of Data; Data Problem; Loss of Data; Data Problem

  IT WAS REPORTED THAT THE PATIENT PATIENT HAS A CODE 574 ON THEIR PATIENT PROGRAMMER. REVIEWED SETTINGS NOT AVAILABLE, NO VALID THERAPY. PATIENT WAS PROGRAMMED 3 WEEKS AGO BY A PHYSICIAN (WHO IS NOT A MOVEMENT DISORDER PHYSICIAN), SINCE THIS TIME THE PATIENT HAS HAD RETURN OF SYMPTOMS, OR LOSS OF THERAPY. REVIEWED WITH CALLER THE PATIENT NEEDS TO BE REPROGRAMMED. PER CALLER, PATIENT IS SELDOM SEEN BY PHYSICIAN AND PRIOR TO 3 WEEKS AGO HAD NOT BEEN SEEN PHYSICIAN SINCE 2017. ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT SOMETHING HAPPENED TO CAUSE THE THERAPY PARAMETERS ON THE IMPLANTABLE NEUROSTIMULATOR (INS) TO BE CLEARED. THE CALLER INDICATED THAT THE PATIENT NOTICED THERE WAS SOMETHING WRONG ABOUT THREE WEEKS AGO. THE CALLER CHECKED THE SYSTEM AND FOUND THE THERAPY PROGRAMMING WAS CLEARED. THE CALLER DID NOT HAVE SPECIFIC DETAILS ABOUT HOW THE PROGRAMMING INFORMATION WAS CLEARED. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE CALLER PROGRAMMED THE PATIENT'S DEVICE DURING THE APPOINTMENT TODAY. THE CALLER CONFIRMED THAT THEY WERE ABLE TO PROGRAM THE INS APPROPRIATELY. THE CALLER PROVIDED THE FOLLOWING PARAMETERS THAT WERE USED

  Patient problems: Insufficient Information

  MAUDE report 13901564 ↗
• MalfunctionNov 23, 2021High impedance; Low impedance; High impedance; Low impedance

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) CLARIFYING THAT THERE WAS NO HIGH IMPEDANCES, ONLY LOW IMPEDANCES ON THE RIGHT SUBTHALAMIC NUCLEUS (STN) LEAD. THE CAUSE OF THE IMPEDANCE ISSUE IS UNKNOWN. THEY ARE NOT USING THE CONTACTS IN PROGRAMMING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862245 ↗
• MalfunctionNov 22, 2021High impedance; Low impedance; High impedance; Low impedance

  IT WAS REPORTED THAT IMPEDANCES ON RIGHT SIDE UNUSED CONTACTS WERE FOUND TO BE OUT OF RANGE DURING PRE-OP INTERROGATION OF PATIENT'S ACTIVA PC, WHICH WAS BEING CHANGED DUE TO BATTERY DEPLETION. IMPEDANCE ISSUES WERE CONSISTENT WHEN CHECKED INTRA-OPERATIVELY ON PATIENT'S NEW PERCEPT PC DEVICE. GENERATOR WAS REPLACED. NO SYMPTOMS WERE REPORTED. THE ISSUE HAS NOT BEEN RESOLVED. PRE-OP SESSION REPORT SHOWED MONOPOLAR C-9 WAS AT 10.9K OHMS. BIPOLAR SHOWED CONTACTS 9-11 WAS AT 9,353OHMS, 10-11 SHOWED LOW, 9-10 WAS AT 9,325OHMS, AND 8-9 SHOWED 11.2KOHMS. THE POST-OP SESSION REPORT SHOWED MONOPOLAR C-9 WAS AT 9,640OHMS AND BIPOLAR CONTACTS 8-9 WAS AT 10,351OHMS, 9-11 WAS AT 10,292OHMS, 9-10 AT 10 ,099OHMS, AND 10-11 WAS AT 36OHMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12857726 ↗
• MalfunctionJun 28, 2021Failure to Deliver Energy; Battery Problem; Failure to Deliver Energy; Battery Problem

  IT WAS REPORTED THAT THE PATIENT'S INS WAS TURNING OFF. THE PATIENT WAS SEEN IN (B)(6) 2021 AND INS VOLTAGE WAS 2.71V. THIS LAST WEEKEND THE PT WIFE REACHED OUT TO CALLER DUE TO INS TURNED OFF. WHEN CHECKING W/ PATIENT PROGRAMMER THE VOLTAGE WAS 2.6 AND READ ERI, AND WAS ABLE TO TURN STIM BACK ON. NO INTERVENTION WITH PATIENT PROGRAMMER WHEN INS TURNED OFF. TODAY ((B)(6) JUN 2021) THE PATIENT STARTED TO HAVE TREMORS, THE INS WAS CHECKED W/ PATIENT PROGRAMMER AND INDICATED THE INS TURNED OFF AGAIN. THE WIFE TURNED INS BACK ON AND NOTED 2.2V AND ERI ON THE PATIENT PROGRAMMER. THE CALLER INDICATED THE INS HAS BEEN ON FOR THE PAST 3 HOURS. THEY WERE DIRECTED TO THEIR PHYSICIAN TO DISCUSS REPLACEMENT.

  Patient problems: Shaking/Tremors

  MAUDE report 12074826 ↗
• MalfunctionMay 11, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PATIENT NOTICED THAT THE INS WAS "NOT WORKING AT ALL." NO SYMPTOMS WERE REPORTED. THE PATIENT ALSO NOTICED THAT THE ERI 'CONTACT CLINICIAN' SCREEN APPEARED ON THEIR PATIENT PROGRAMMER; THE PATIENT NOTED THAT THE INS BATTERY VOLTAGE WAS 2.61. DURING THE CALL, THE PATIENT CONFIRMED THEIR INS WAS TURNED ON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11809547 ↗
• MalfunctionJan 28, 2021Break; Display or Visual Feedback Problem; High impedance; Unintended Collision; Break; Display or Visual Feedback Problem; High impedance; Unintended Collision

  ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REPORTING NO ACTIONS HAVE BEEN TAKEN TO RESOLVE THE BROKEN LEAD.

  Patient problems: Ambulation or Postural Difficulties; Cramp(s) /Muscle Spasm(s); Dysphasia; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 11242829 ↗
• InjuryJan 22, 2021High impedance; Unstable; Material Deformation; High impedance; Unstable; Material Deformation

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE NEUROSTIMULATOR WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11217511 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THEIR IMPLANTABLE NEUROSTIMULATOR (INS) LOOKED BRUISED AROUND THE CORNER. THEY STATED THAT THEIR SURGEON CHECKED THE INS AND TOLD THE PATIENT THAT THEY "MAY HAVE BUMPED IT OR SOMETHING LIKE THAT". THE INS EVENTUALLY PERFORATED TO THE SKIN MORE THAN AN INCH AND A QUARTER ON ONE SIDE, AND AT LEAST A HALF INCH ON THE OTHER SIDE. THEY ADDED THAT THE INS WAS "TOTALLY STICKING OUT". THE INS WAS REPLACED AND THE ISSUE WAS RESOLVED.

  Patient problems: Bruise/Contusion; Pocket Erosion; Unspecified Infection

  MAUDE report 11148100 ↗
• InjuryDec 18, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT ABOUT 2 WEEKS AGO, THE PATIENT'S RIGHT SIDE IMPLANTABLE NEUROSTIMULATOR (INS) WAS BOTHERING THEM, NOTING THAT THE PATIENT'S NECK WAS HURTING. YESTERDAY, THE PATIENT "FELT LIKE IT WAS BURNING INSIDE WHERE THE BATTERY IS." THEY TURNED THE PATIENT'S INS OFF AND THE PATIENT NO LONGER FELT THE BURNING SENSATION. THEY CONFIRMED THAT THE PATIENT HAS NOT HAD ANY FALLS OR TRAUMA. THEY CONFIRMED THERE IS NO ISSUE WITH THE INS ON THE PATIENT'S LEFT SIDE AND IT IS CURRENTLY TURNED ON. THEY REPORTED THIS ISSUE TO THE PATIENT'S HEALTHCARE PROVIDER (HCP) AND THE HCP SCHEDULED TO HAVE THE INS REPLACED YESTERDAY. ALTHOUGH THE INS WAS SCHEDULED TO BE REPLACED, THE PATIENT MENTIONED THAT THE INS WAS NEVER CHECKED. THE PATIENT WENT TO HAVE THE INS REPLACED, BUT THEY WERE TOLD THAT THE HCP WAS UNABLE TO REPLACE THE INS AT THIS TIME DUE TO COVID-19 PANDEMIC, SO THE APPOINTMENT WAS RESCHEDULED FOR (B)(6). THEY INQUIRED ABOUT WHAT THE PATIENT'S OPTIONS ARE IN THE MEANTIME. THEY WILL CONTACT A MANUFACTURER REPRESENTATIVE (REP) TO INQUIRE IF THEY CAN ASSIST. THE ROLE OF A REP WAS REVIEWED.

  Patient problems: Burning Sensation; Discomfort; Neck Pain

  MAUDE report 11037526 ↗
• InjuryDec 15, 2020Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE THERAPY ISSUE DID NOT RESOLVE EVEN AFTER MANY PROGRAMMING COMBINATIONS WERE TRIED WITH VERY LITTLE BENEFIT. THE ENTIRE SYSTEM WAS EXPLANTED AND WAS IN HOSPITAL POSSESSION WITH NO PLAN TO RETURN THE DEVICES PER HOSPITAL POLICY.

  Patient problems: Insufficient Information

  MAUDE report 11007802 ↗
• InjuryDec 8, 2020Malposition of Device; Malposition of Device

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAD A FULL SYSTEM EXPLANT DUE TO SUBOPTIMAL LEAD LOCATION. THE NEW BATTERY AND LEAD WERE BEING PLACED (B)(6) 2020.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10970039 ↗

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-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.