BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 12658063 · Received October 19, 2021

    Report

    Report Number
    3006630150-2021-05847
    Event Type
    Injury
    Date Received
    October 19, 2021
    Date of Event
    September 9, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), LOT: 7080357. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), LOT: 7083551. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), LOT: 7087586. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, LOT: 26656775.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE RETROAURICULAR INCISION AND IMPLANTABLE PULSE GENERATOR IPG SITE. THE DRAINAGE WAS UNABLE TO BE RESOLVED WITH ORAL KEFLEX. THEREFORE, THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE AND WAS ADMINISTERED IV CEFAZOLIN FOR TWO WEEKS. THE PATIENT IS CURRENTLY HEALED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555176 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 508560 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R