BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17897368 · Received October 9, 2023

    Report

    Report Number
    3006630150-2023-06120
    Event Type
    Injury
    Date Received
    October 9, 2023
    Date of Event
    September 12, 2023
    Report Date
    October 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7094591. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7100489. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7112582. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7112126.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT UNDERWENT A PROCEDURE WHERE THE IPG, LEADS AND LEAD EXTENSIONS WERE REMOVED. PHYSICAL ANALYSIS OF THE DBS DEVICES WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY AND THE PATIENT DID WELL POST-OPERATIVELY. ADDITIONAL INFORMATION WOULD NOT BE PROVIDED BY THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2003386 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 572273 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention