BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 15060120 · Received July 19, 2022

    Report

    Report Number
    3006630150-2022-03549
    Event Type
    Injury
    Date Received
    July 19, 2022
    Date of Event
    April 1, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANT DATE: (B)(6) 2022 (EXACT DATE UNKNOWN). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(4), BATCH: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7070181 AND 7070282.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG, IMPLANTABLE PULSE GENERATOR, SITE. THE PATIENT UNDERWENT AN EXPLANT OF THE IPG AND THE ADAPTERS AS A PRECAUTION, IT WAS NOTED THAT THE INFECTION WAS NOT DEVICE RELATED. CULTURES WERE TAKEN BUT THE RESULTS ARE UNKNOWN. THE PATIENT WAS WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IPG, IMPLANTABLE PULSE GENERATOR, SITE. THE PATIENT UNDERWENT AN EXPLANT OF THE IPG AND THE ADAPTERS AS A PRECAUTION, IT WAS NOTED THAT THE INFECTION WAS NOT DEVICE RELATED. CULTURES WERE TAKEN BUT THE RESULTS ARE UNKNOWN. THE PATIENT WAS WELL POSTOPERATIVELY. IT WAS ADDITIONALLY REPORTED THAT THE IPG SITE WAS RED AND THE PATIENT WAS PLACED ON ANTIBIOTICS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DESTROYED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877097 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 742137 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention