BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 20909461 · Received December 11, 2024

    Report

    Report Number
    3006630150-2024-08654
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    November 10, 2024
    Report Date
    December 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    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: EXACT DATE UNKNOWN, EVENT OCCURRED THE WEEK OF NOVEMBER 10TH, 2024 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7130033. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7130200.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED SWELLING, REDNESS, HOT TO THE TOUCH, AND PAIN AROUND THEIR IMPLANTABLE PULSE GENERATOR (IPG) AND EXTENSIONS. IT WAS ASSESSED THAT THE PATIENT HAD DEVELOPED AN INFECTION. A CULTURE WAS TAKEN; HOWEVER, THE RESULTS ARE UNKNOWN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THEIR IPG AND EXTENSIONS WERE EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICES WERE DISCARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED SWELLING, REDNESS, HOT TO THE TOUCH, AND PAIN AROUND THEIR IMPLANTABLE PULSE GENERATOR (IPG) AND EXTENSIONS. IT WAS ASSESSED THAT THE PATIENT HAD DEVELOPED AN INFECTION. A CULTURE WAS TAKEN; HOWEVER, THE RESULTS ARE UNKNOWN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THEIR IPG AND EXTENSIONS WERE EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE DEVICES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2062889 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 761618 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention