NA 66700Recalls & reported problems
Advanced Neuromodulation Systems, Inc. · DBS Charging System · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05415067051899), received between May 4, 2026 and May 4, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Smoking” (1 report).
5 other recalls cover devices cleared under the same FDA submission (P140009); 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.
Reports received per month
Most reported problems
Device problems
- Smoking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 4, 2026Smoking
IT WAS REPORTED THAT THE PATIENT SAW SMOKE COMING FROM THEIR CHARGER. AS A RESULT, A REPLACEMENT CHARGER WAS SENT TO THE PATIENT WHICH RESOLVED THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25070255 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140009. One submission often covers many models, so check the product and lot details in each record.
- Z-0459-2026 · Oct 6, 2025 · Open, ClassifiedLiberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
- Z-2696-2017 · Jun 2, 2017 · TerminatedInfinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
- Z-2695-2017 · Jun 2, 2017 · TerminatedInfinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
- Z-2693-2017 · Jun 2, 2017 · TerminatedInfinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions.
- Z-2694-2017 · Jun 2, 2017 · TerminatedInfinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
Other Stimulator, electrical, implanted, for parkinsonian symptoms devices
- ACTIVA RC 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS2,839 reports
- Activa® 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS1,325 reports
- Percept™ RC B35300Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian symptoms1 recall3 deaths796 reports
- Vercise™ Cartesia™ DB-2202-45Boston Scientific Neuromodulation Corporation · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS18 deaths718 reports
- Activa® PC 37601Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS3 deaths521 reports
- Activa® RC 37612Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian symptoms1 death469 reports
- Activa® RC 37612Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian symptoms410 reports
- NA NM-3138-55Boston Scientific Neuromodulation Corporation · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS198 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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