BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 16763055 · Received April 18, 2023

    Report

    Report Number
    3006630150-2023-02092
    Event Type
    Injury
    Date Received
    April 18, 2023
    Date of Event
    March 24, 2023
    Report Date
    April 18, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7070864. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: (B)(4), MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7072591. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: 7083447 BATCH: 7083447 PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: 7083068 BATCH: 7083068 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 26287596 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 26248509.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AND INFECTION AND UNDERWENT AN EXPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION DBS SYSTEM. THE CAUSE OF THE INFECTION WAS NOT IDENTIFIED HOWEVER THE PHYSICIAN BELIEVES THAT THERE MAY HAVE BEEN A CAUSE OTHER THAN THE DEVICE. NOTHING HAPPENED DURING THE DBS PROCEDURE THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION. THE PATIENT THEN LATER WAS RE-IMPLANTED WITH A NEW DBS SYSTEM. THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS SINCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562263 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1416 201396 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown Required Intervention