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Vercise™ DB-64125-USRecalls & reported problems

Boston Scientific Neuromodulation Corporation · Charging System · Class 3 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729965848), received between Nov 1, 2018 and Nov 1, 2018 — classified as 1 injury.

4 other recalls cover devices cleared under the same FDA submission (P150031); 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

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Neurological Deficit/Dysfunction1
  • Numbness1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A REPORT WAS RECEIVED THAT ON THREE SEPARATE OCCASIONS THE PATIENT EXPERIENCED MULTIPLE SYMPTOMS DUE TO CHARGING HIS IPG. THE PATIENT REPORTED THAT WITHIN ONE MINUTE OF PUTTING HIS CHARGER ON HIS IPG HE HAS EXPERIENCED PAIN AND NUMBNESS FROM HIS FEET TO HIS ENTIRE BODY, COLD SWEATS, SLURRED SPEECH, A METAL TASTE IN HIS MOUTH, THROAT TIGHTENING, SHORTNESS OF BREATH, AND STROKE LIKE SYMPTOMS. THE PATIENT REPORTED THAT THE SYMPTOMS LAST FOR THE REMAINDER OF THE DAY BUT RESOLVE BY THE NEXT DAY. THE PATIENT'S CHARGER WAS REPLACED AND HE REPORTED NO ISSUES WITH THE NEW CHARGER.

    Patient problems: Neurological Deficit/Dysfunction; Numbness; Pain

    MAUDE report 8031262 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150031. One submission often covers many models, so check the product and lot details in each record.

  • Z-2340-2025 · Jul 8, 2025 · Open, Classified
    Burr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0. Components of Vercise Deep Stimulation System used with the Surgical Implant Manual
  • Z-2558-2025 · Jul 8, 2025 · Open, Classified
    Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
  • Z-1890-2024 · Apr 18, 2024 · Open, Classified
    Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT, REF: M365DB12160, and R32 IPG KIT, REF: M365DB12320
  • Z-2125-2020 · Apr 24, 2019 · Terminated
    Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Brain Stimulation (DBS) System is indicated for use in bilateral stimulation of the

Other STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.