BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 13607792 · Received February 25, 2022

    Report

    Report Number
    3006630150-2022-00716
    Event Type
    Injury
    Date Received
    February 25, 2022
    Date of Event
    January 26, 2022
    Report Date
    February 25, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7090352. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7091254.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH REDNESS AND SWELLING AROUND THE IMPLANTABLE PULSE GENERATOR (IPG) AS WELL AS THE LEAD EXTENSION SITES. THE PHYSICIAN ASSESSED THAT THE PATIENT HAD AN INFECTION AND WAS ADMINISTERED ORAL ANTIBIOTICS AS WELL AS HAD THE SURGICAL SITE IN THE CHEST AND HEAD FLUSHED WITH ANTIBIOTICS. A CULTURE WAS TAKEN BUT THE RESULTS ARE UNKNOWN. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2407429 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 516796 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| R