Activa SCRecalls & reported problems across all models
Medtronic, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Activa SC model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,753
- Deaths reported
- 7
- Injuries reported
- 748
- Recalls
- 1
We found 10 models of Activa SC by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,753 adverse event reports in the FDA's MAUDE database, received between May 1, 2017 and Sep 8, 2026 — classified as 7 deaths, 748 injuries, 998 malfunctions.
The most frequently reported specific device problem is “High impedance” (270 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Reports received per month, all models
Activa SC recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 15, 2024Open, Classified
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
Z-2427-2024 · Root cause: Under Investigation by firm · names 9 of these models · Recall details · FDA record ↗
Most reported Activa SC problems
Device problems
- Adverse Event Without Identified Device or Use Problem399
- High impedance270
- Insufficient Device Problem Information200
- Battery Problem198
- Low impedance169
- Energy Output Problem148
- Inappropriate/Inadequate Shock/Stimulation130
- Failure to Deliver Energy114
Patient problems
- No Clinical Signs, Symptoms or Conditions523
- No Known Impact Or Consequence To Patient255
- Shaking/Tremors218
- Insufficient Information188
- Unspecified Infection160
- Electric Shock134
- Complaint, Ill-Defined124
- Ambulation or Postural Difficulties93
Activa SC models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Activa® SC 37603STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall1 death443 reports
- ACTIVA® SC 37603STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 death330 reports
- Activa® SC 37602implanted subcortical electrical Stimulator (motor disorders)1 recall1 death228 reports
- ACTIVA® SC 37602STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall2 deaths197 reports
- Activa® SC 37603Stimulator, electrical, implanted, for parkinsonian symptoms1 recall2 deaths118 reports
- Activa® SC 37603Stimulator, electrical, implanted, for essential tremor1 recall111 reports
- Activa® SC 37603Stimulator, electrical, implanted, for parkinsonian tremor1 recall108 reports
- Activa® SC 37602Stimulator, electrical, implanted, for essential tremor1 recall85 reports
- Activa® SC 37602Stimulator, electrical, implanted, for parkinsonian symptoms1 recall74 reports
- Activa® SC 37602implanted subcortical electrical Stimulator (motor disorders)1 recall59 reports
Recent Activa SC adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Electromagnetic Compatibility Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677935 ↗MalfunctionSep 8, 2026Electromagnetic Compatibility Problem
Additional information received from manufacturer representative (rep), cause of artifacts remains unknown but it is suspected that the multiple devices are contributing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677905 ↗InjuryAug 18, 2026Premature Discharge of Battery
It was reported that the caller said the patient (pt) had their right battery replaced in April and at that time the left battery was at 100%. Caller said 3 weeks ago the battery dropped to 75% and the next week it dropped to 50% then in a few days it dropped to 0. Caller saw an EOS message on the pt programmer. Caller said the healthcare provider (HCP) told them it was very unusual for the INS battery to deplete this fast. PSS reviewed the implantable neurostimulator (INS) battery level doesn't show a percentage that it shows ok or low and a voltage. Patient Services (PSS) asked if they could have been looking at the patient programmer battery level. Caller communicated w/ the INS and saw an EOS message which they were not able to bypass. Caller said the pt is completely immobile because the INS is depleted. Caller got a call from a nurse and had to end the call.
Patient problems: Ambulation or Postural Difficulties
MAUDE report 50308454 ↗InjuryJul 30, 2026Malposition of Device
It was reported that It was reported that the patient (pt) needed to go to the ER this weekend because they think pt is having gallbladder and appendix issues and their smart programmer is lost or stolen and they may need to turn therapy off for surgery. It was also reported that the caller said patient (pt) has been going to a doctor out of state even though they live elsewhere because the doctor who put in their most current implantable neurostimulator ((b)(6)2023) installed their wiring all wrong. Caller said the wiring was choking the pt because it crisscrossed in the front of their neck and they were flown to have it taken out and redone. Redirected to their doctor.
Patient problems: Choking
MAUDE report 50084107 ↗InjuryJul 30, 2026Malposition of Device
It was reported that the patient needed to go to the ER this weekend because they think patient is having gallbladder and appendix issues and their smart programmer is lost or stolen and they may need to turn therapy off for surgery. It was also reported that the caller said patient has been going to a doctor out of state even though they live elsewhere because the doctor who put in their most current implantable neurostimulator (on (b)(6) 2023) installed their wiring all wrong. Caller said the wiring was choking the patient because it crisscrossed in the front of their neck and they were flown to have it taken out and redone. Redirected to their doctor.
Patient problems: Choking
MAUDE report 50084100 ↗InjuryJul 30, 2026High impedance; Impedance Problem
It was reported that patient had some impedance issue showing as investigate that would not clear, so the neurosurgeon decided to replace the lead, extension, and battery. No known cause or contributors to this issue. Issue is considered resolved on replacement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50083875 ↗InjuryJul 30, 2026Inappropriate/Inadequate Shock/Stimulation
The manufacturer representative provided additional information indicating that the cause of the shocking sensation was not determined and no contributing factors were identified. The physician switched the settings to mA, but no other corrective steps are known at this time. Resolution status is unknown because the patient has not yet responded to follow-up. The information was confirmed by the physician.
Patient problems: Electric Shock
MAUDE report 50083758 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT HAD THE BATTERIES REPLACED LAST WEEK BECAUSE IT WAS PROBABLY OVERDUE. PATIENT HAD BEEN HAVING PHYSICAL DISCOMFORT SO THEY GOT THE BATTERY REPLACED.
Patient problems: Discomfort
MAUDE report 25752729 ↗MalfunctionJul 8, 2026Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS IMPLANTED AFTER ITS USE BEFORE DATE (UBD). THE IMPLANT DATE WAS (B)(6) 2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25748905 ↗MalfunctionJul 8, 2026Break; Adverse Event Without Identified Device or Use Problem
Patient problems: Fall
MAUDE report 25748503 ↗MalfunctionJul 8, 2026Break
Patient problems: Fall
MAUDE report 25748458 ↗InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT (PT) SCHEDULED FOR ROUTINE BATTERY CHANGE (ERI) FOR LEFT IMPLANT. NOTICED LUMP ON NECK AND SWELLING AT IMPLANTABLE NEUROSTIMULATOR (INS) SITE. THERE WAS A CONCERN FOR INFECTION, CULTURES WERE TAKEN AND THE LEFT SYSTEM WAS EXPLANTED. MANUFACTURER REPRESENTATIVE (REP) INDICATES THE ISSUE WAS RESOLVED.
Patient problems: Insufficient Information; Swelling/ Edema; Unspecified Infection
MAUDE report 25152991 ↗MalfunctionMay 5, 2026Battery Problem
IT WAS REPORTED THAT THE NEUROSTIMULATOR WAS INTERROGATED IN ORDER TO ACTIVATE IT PRIOR TO USE AND THE IMPLANT WAS NOTED TO BE DISCHARGED MORE THAN WAS EXPECTED OR NORMAL WHILE SITTING IDLE. THERE WERE NO PATIENT FACTORS ASSOCIATED WITH THIS EVENT AS THIS DEVICE WAS NEVER IMPLANTED. IT IS STILL IN THE ORIGINAL MANUFACTURER PACKAGING. NO ACTIONS WERE TAKEN AND THE ISSUE IS NOT RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25087328 ↗MalfunctionApr 27, 2026High impedance; Unintended Collision
IT WAS REPORTED THAT CONTACT 0 DISPLAYING IMPEDANCE VALUES > 20,000 OHMS. NO SYMPTOMS TO PATIENT AS A RESULT OF HIGH IMPEDANCES. PATIENT IS PROGRAMMED IN BIPOLAR CONFIGURATION W 2 - AND 3 + . IMPEDANCES HAVE BEEN HIGH ON LEFT SIDE EVER SINCE A MAJOR CAR ACCIDENT SEVERAL YEARS AGO. THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THIS REPORT. REP NOTED THE HIGH IMPEDANCE HAS NOT AFFECTED THE PATIENT'S THERAPY. REP REPORTS THE CAUSE OF THE IMPEDANCES IS NOT KNOWN AND NO TROUBLESHOOTING WILL BE DONE BY THE HEALTHCARE PROVIDER (HCP). THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE REPLACEMENT OF THE TWO IMPLANTABLE NEUROSTIMULATORS WAS DUE TO NORMAL BATTERY DEPLETION RATHER THAN HIGH IMPEDANCE. THE INFORMATION WAS CONFIRMED BY THE PHYSICIAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002915 ↗MalfunctionApr 27, 2026High impedance; Unintended Collision
IT WAS REPORTED THAT CONTACT 0 DISPLAYING IMPEDANCE VALUES > 20,000 OHMS. NO SYMPTOMS TO PATIENT AS A RESULT OF HIGH IMPEDANCES. PATIENT IS PROGRAMMED IN BIPOLAR CONFIGURATION W 2 - AND 3 + . IMPEDANCES HAVE BEEN HIGH ON LEFT SIDE EVER SINCE A MAJOR CAR ACCIDENT SEVERAL YEARS AGO. THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THIS REPORT. REP NOTED THE HIGH IMPEDANCE HAS NOT AFFECTED THE PATIENT'S THERAPY. REP REPORTS THE CAUSE OF THE IMPEDANCES IS NOT KNOWN AND NO TROUBLESHOOTING WILL BE DONE BY THE HEALTHCARE PROVIDER (HCP). THE MANUFACTURER REPRESENTATIVE PROVIDED ADDITIONAL INFORMATION INDICATING THAT THE REPLACEMENT OF THE TWO IMPLANTABLE NEUROSTIMULATORS WAS DUE TO NORMAL BATTERY DEPLETION RATHER THAN HIGH IMPEDANCE. THE INFORMATION WAS CONFIRMED BY THE PHYSICIAN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25002512 ↗
Other Medtronic, Inc. products
- CapSureFix Novus MRI SureScan29 models · 87,337 reports
- Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
- Intellis AdaptiveStim3 models · 35,469 reports
- SYNCHROMED II11 models · 32,260 reports · 4 recalls
- CAPSUREFIX NOVUS17 models · 27,547 reports
- INTERSTIM30 models · 24,415 reports · 1 recall
- Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
- Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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