BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 19347768 · Received May 17, 2024

    Report

    Report Number
    3006630150-2024-03210
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    May 1, 2024
    Report Date
    August 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300 MODEL: DB-2202-30 SERIAL: (B)(6) BATCH: 7083094. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300 MODEL: DB-2202-30 SERIAL: (B)(6) BATCH: 7083202 PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7124125. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7124141. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: NULL BATCH: 32891460 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: NULL BATCH: 32891460.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG) THAT AFFECTED THE WHOLE SYSTEM ALONG THE EXTENSIONS UP TO THE HEAD WHERE THE LEADS WERE IMPLANTED AND SHOWED SIGNS OF INFLAMMATION AND REDNESS OF THE SKIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A FULL SYSTEM EXPLANT WHERE THE IPG, LEADS, LEAD EXTENSIONS, AND BURR HOLE COVERS WERE REMOVED. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE FACILITY AND WERE NOT RETURNED TO BSC. ADDITIONAL INFORMATION WAS RECEIVED INDICATING A CULTURE WAS TAKEN AND CAME BACK POSITIVE FOR STAPHYLOCOCCUS AUREUS AND STAPHYLOCOCCUS CAPITIS. ANTIBIOTICS WERE ADMINISTERED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND ADMINISTERED MEDICATION FOR PARKINSONS DISEASE. THE EXPLANT DATE OF THE FULL SYSTEM WAS ALSO PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG) THAT AFFECTED THE WHOLE SYSTEM ALONG THE EXTENSIONS UP TO THE HEAD WHERE THE LEADS WERE IMPLANTED AND SHOWED SIGNS OF INFLAMMATION AND REDNESS OF THE SKIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A FULL SYSTEM EXPLANT WHERE THE IPG, LEADS, LEAD EXTENSIONS, AND BURR HOLE COVERS WERE REMOVED. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669458 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 595783 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H