BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 11051723 · Received December 21, 2020

    Report

    Report Number
    3006630150-2020-06309
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    December 9, 2020
    Report Date
    January 7, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A SEVERE SUBDURAL HEMATOMA FOLLOWING THE IMPLANT PROCEDURE. PATIENT UNDERWENT AN EMERGENCY CRANIOTOMY. PHYSICIAN ASSESSED THE EVENT TO BE POSSIBLY RELATED TO THE SURGERY, UNLIKELY RELATED TO STIMULATION, AND NOT RELATED TO THE DEVICE HARDWARE. ADDITIONAL INFORMATION RECEIVED THAT POST IMPLANT PROCEDURE THE PATIENT WAS SLOW TO WAKE FROM SURGERY AND PUPILS WERE EQUAL BUT SLUGGISHLY REACTIVE. CT IMAGING WAS TAKEN WHICH REVEALED AN ACUTE LEFT SUBDURAL HEMATOMA. THE PATIENT UNDERWENT AN EMERGENCY CRANIOTOMY TO EVACUATE THE HEMATOMA AND THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 5115683. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 5177004.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SEVERE SUBDURAL HEMATOMA FOLLOWING THE IMPLANT PROCEDURE. PATIENT UNDERWENT AN EMERGENCY CRANIOTOMY. PHYSICIAN ASSESSED THE EVENT TO BE POSSIBLY RELATED TO THE SURGERY, UNLIKELY RELATED TO STIMULATION, AND NOT RELATED TO THE DEVICE HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1508851 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 741331

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention