Activa PCRecalls & reported problems across all models

We found 7 models of Activa PC by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 3,316 adverse event reports in the FDA's MAUDE database, received between Jul 12, 2013 and Sep 17, 2026 — classified as 24 deaths, 1,542 injuries, 1,750 malfunctions.

The most frequently reported specific device problem is “High impedance” (532 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Activa PC problems

Activa PC models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ACTIVA PC 37601

  implanted subcortical electrical Stimulator (motor disorders)
  15 deaths1,625 reports
• Activa® PC 37601

  STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  3 deaths521 reports
• Activa® PC 37601

  implanted subcortical electrical Stimulator (motor disorders)
  1 death502 reports
• Activa® PC 37601

  STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED
  3 deaths410 reports
• Activa® PC 37601

  Deep brain stimulator for obsessive compulsive disorder (OCD)
  122 reports
• Activa® PC 37601

  Deep brain stimulator for obsessive compulsive disorder (OCD)
  2 deaths115 reports
• Activa® PC 37601

  Deep brain stimulator for obsessive compulsive disorder (OCD)
  21 reports

Recent Activa PC adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50810807 ↗
• InjuryAug 18, 2026Failure to Deliver Energy; Adverse Event Without Identified Device or Use Problem

  It was reported that patient got an infection of the lead Oct 2024, and healthcare provider (HCP) waited until it cleared before implanting in Dec. 2024. Caller reported that symptoms were bad since patient was without therapy. Agent redirected caller back to HCP and gave a few listing of HCP for caller to inquire about finding a different doctor to reprogram patient.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 50308165 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WHOLE SYSTEM OF DBS WAS EXPLANTED 2018 DUE TO INFECTION. FURTHER RESEARCH REQUIRED FOR DATE OF EXPLANT. EXACT DATE OF EXPLANT REMAINS UNKNOWN. RESOLUTION IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 25781830 ↗
• InjuryJun 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PREVIOUS INS BATTERY WAS REPLACED BECAUSE THE "BATTERY WAS BAD.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25587363 ↗
• MalfunctionJun 22, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT HAD THEIR FIRST SURGERY IN 2016. HIGH IMPEDANCE WAS FIRST NOTED ON CONTACT 0 IN 2017. MULTIPLE ABNORMAL IMPEDANCES WERE NOTED ON CONTACTS 8, 9, AND 11 BEFORE ON (B)(6) 2022 SURGERY. THE LAST NOTE SHOWS HIGH IMPEDANCE ON LEFT LEAD CONTACT 0 - >5K MONOPOLAR AND >10K BIPOLAR AND RIGHT LEAD CONTACTS 11 (2994), 9 (2767), AND 8 (3661) MONOPOLAR AND BIPOLAR. THE ETIOLOGY WAS POSSIBLY RELATED TO THE DEVICE/THERAPY - LEADS). THE CONTACTS HAVE BEEN AVOIDED; NO ACTIONS TAKEN. THE ISSUE IS UNRESOLVED WITH NO FURTHER ACTION PLANNED. THERE WERE NO PATIENT SYMPTOMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25582475 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CALLER INITIALLY STATED THAT THE PATIENT HAD 4 LEADS BUT HAD TO HAVE 2 OF THEM REMOVED ON (B)(6) 2026 DUE TO AN ABSCESS. CALLER WANTED TO KNOW IF PATIENT IS STILL MRI CONDITIONAL OR IF THIS AFFECTS MRI ELIGIBILITY. AGENT REVIEWED PATIENT'S IMPLANT RECORDS AND THAT SHOWED MANUFACTURER SYSTEM (WITH 2 LEADS) WAS IMPLANTED IN 2019. HOWEVER, CALLER STATED THAT PATIENT HAD NON-MANUFACTURER LEADS IMPLANTED ON (B)(6) 2021 BUT THE NOTES DIDN'T INDICATE IF THE MANUFACTURER COMPONENTS HAD BEEN EXPLANTED. CALLER WAS GOING TO LOOK FURTHER INTO WHAT THE PATIENT CURRENTLY HAS IMPLANTED. AGENT REVIEWED THAT IF, BY CHANCE, PATIENT HAS A MIXED SYSTEM, WE WOULD NOT RECOMMEND MRIS. SINCE THE STATUS OF THE MANUFACTURER IMPLANTABLE NEUROSTIMULATOR, EXTENSIONS AND LEADS ARE UNKNOWN, IT IS UNKNOWN IF THE ABSCESS ON MAY 5, 2026 IS RELATED TO THE MANUFACTURER OR NON-MANUFACTURER DEVICES.

  Patient problems: Abscess; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25427355 ↗
• MalfunctionMay 29, 2026Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT NOTIFIED A MANUFACTURER REPRESENTATIVE (REP) THAT THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAD MOVED AROUND SINCE IMPLANTATION AND IT HITS THEIR RIBS. FOLLOW UP WAS COMPLETED TO OBTAIN ADDITIONAL INFORMATION AND THE REP INDICATED THAT CAUSE WAS NOT DETERMINED, NO ACTIONS WERE TAKEN TO ADDRESS THIS, AND ISSUE REMAINS UNRESOLVED. THIS INFORMATION WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25333219 ↗
• InjuryMay 25, 2026Insufficient Device Problem Information

  IT WAS REPORTED BY AN ALLIED HEALTHCARE PROVIDER AND PATIENT REPRESENTATIVE THAT THE PATIENT WAS CURRENTLY HOSPITALIZED DUE TO AN ABRUPT RETURN OF UNCONTROLLABLE DYSKINESIA FOR THE PAST SEVERAL DAYS. IT WAS REPORTED THAT SIMILAR SYMPTOMS HAD OCCURRED IN THE PAST WHEN DEEP BRAIN STIMULATION WAS TURNED OFF AND RECALIBRATED, AND THAT THE DEVICE HAD NOT BEEN CHECKED SINCE 2020. THE PATIENT WAS UNABLE TO EAT, HOLD A DRINK, AND SLID OFF A COUCH BECAUSE OF THE DYSKINESIA. THE PATIENT REP DESCRIBED THE PATIENT AS FLOPPING ALL OVER WITHOUT CEASING. COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED AND NOTHING WAS REPORTED TO BE OBSERVED IN RESPECT TO THE DEEP BRAIN SYSTEM. INFECTION WAS RULED OUT. THE PATIENT REPRESENTATIVE WAS UNSURE IF THE IMPLANTABLE NEUROSTIMULATOR AND/OR PROGRAMMER WAS FUNCTIONAL. ADDITIONALLY, PATIENT REPRESENTATIVE REPORTED THAT PATIENT WAS EXPERIENCING HALLUCINATIONS AND MENTAL STATUS, BUT WERE UNSURE IF WAS RELATED TO THE DEEP BRAIN STIMULATION (DBS) THERAPY/DEVICE OR RELATED TO A KNOWN PROSTATE ISSUE THAT WAS DESCRIBED AS PRE-EXISTING. THE PATIENT REPRESENTATIVE REPORTED THAT PATIENT HAD A HISTORY OF BLADDER RETENTION WITH LAST EVENT TAKING PLACE ABOUT A YEAR EARLIER.

  Patient problems: Ambulation or Postural Difficulties; Cognitive Changes; Dyskinesia; Insufficient Information

  MAUDE report 25271554 ↗
• MalfunctionMay 18, 2026Break; Insufficient Device Problem Information

  IT WAS REPORTED THAT AT ROUTINE ERI BATTERY CHANGE FOR RIGHT IMPLANT TODAY, RECEIVED NOTES FROM NURSE THAT WERE UNCLEAR AS TO WHEN PATIENT SEEN LAST BY FELLOWS AND DOCUMENTATION ABOUT LEADS. UNCLEAR IF RIGHT LEAD INTO THIS IMPLANT IS CUT OR JUST NOT PROGRAMMED OR FOR WHAT REASON. TOLD LEFT CHEST HAS IMPLANT THAT IS NOT TO HAVE IMPEDANCES CHECKED ON BECAUSE THAT LEAD HAS BEEN CUT UP NEAR BHD AND IMPEDANCE TEST CAUSES DISCOMFORT SENSATION. ASKED FOR MORE DETAILS BUT NURSE DID NOT KNOW THE DETAILS AS IT WAS A FORMER FELLOW WHO MANAGED THE PATIENT AND NO ADDITIONAL DETAILS IN NOTES. NO FURTHER ACTION IS PLANNED AT THIS TIME.

  Patient problems: Discomfort

  MAUDE report 25202535 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THEY HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED WITH A RECHARGEABLE INS 2-3 DAYS AGO, BECAUSE THEIR OLD INS HAD DIED 2 AND A HALF MONTHS AGO, BUT THEY STILL HAVE "SHAKES". AGENT WALKED THEM THROUGH CONNECTING TO THE INS AND WAS ABLE TO CONFIRM THAT THE THERAPY IS ON. AGENT DOCUMENTED REPORTED EVENTS AND REDIRECTED THEM TO THE HCP TO FURTHER ADDRESS THE ISSUE.

  Patient problems: Shaking/Tremors

  MAUDE report 25137989 ↗
• MalfunctionMay 1, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS HAVING PROBLEMS WITH THEIR BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059413 ↗
• InjuryMay 1, 2026Failure to Interrogate; Battery Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THEY ARE DOING A DBS BATTERY REPLACEMENT FOR THE PATIENT AND THEY ARE NOT ABLE TO FIND THE PART NUMBERS FOR THE EXTENSIONS OR LEADS ANYWHERE IN THE NOTES. REPRESENTATIVE STATES THE PATIENT'S BATTERY IS ""COMPLETELY DEAD"" AND THEY CAN'T PULL THE SETTINGS FROM THE BATTERY. AGENT ASKED FOR EVENT DATE AND CALLER STATES ""SOMETIME IN THE LAST MONTH OR SO"" AND WHEN THEY CHECKED THE PROCEDURE NOTE FROM 2 WEEKS AGO, THE PATIENT SAID THEY CAME TO THE OFFICE AND THE BATTERY WAS DEAD. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25058712 ↗
• InjuryMar 30, 2026Battery Problem

  IT WAS REPORTED THAT PATIENT (PT) IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED BECAUSE, IT KEPT LOSING IT'S POWER. NO FURTHER I NFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24717046 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD TWO DBS IMPLANTS FOR DYSTONIA AND NEITHER OF THEM WORKED. CALLER DID NOT KNOW WHY. CALLER STATED THE FIRST ONE WAS IMPLANTED BY AN HCP WHO LOST THEIR LICENSE. THE 2ND TIME PATIENT WENT TO A NEW PHYSICIAN AND THEY WENT THROUGH ALL THE SETTINGS.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 24634650 ↗
• InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EXPOSED IMPLANTED HARDWARE, WOUND DEHISCENCE, AND INFECTION OCCURRED. THE PATIENT REPORTED AN UNRELATED SKIN INJURY TWO WEEKS PRIOR TO PRESENTING TO MEDICAL STAFF, STATING THE INJURY WAS THE RESULT OF A FALL. EXAMINATION CONFIRMED WOUND DEHISCENCE AND EXPOSED HARDWARE. THE HARDWARE, INCLUDING THE LEAD, EXTENSION, AND IMPLANTABLE PULSE GENERATOR (IPG), WAS FUNCTIONING PROPERLY BUT WAS REMOVED DUE TO INFECTION. THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED. THE WOUND HEALED, AND THE PATIENT OPTED NOT TO RE-IMPLANT. THE EVENT WAS ASSESSED AS NOT RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 24501472 ↗

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