BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17261088 · Received July 5, 2023

    Report

    Report Number
    3006630150-2023-03901
    Event Type
    Injury
    Date Received
    July 5, 2023
    Date of Event
    February 1, 2023
    Report Date
    July 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45 , SERIAL: (B)(6), BATCH: 7087706. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55 , SERIAL: (B)(6), BATCH: 7093810. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55 , SERIAL: (B)(6), BATCH: 7093843.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO POOR WOUND CLOSURE/HEALING AT INCISION SITE. THE PHYSICIAN ASSESSED THAT AN INFECTION WAS NOT SUSPECTED AND WAS CONFIDENT THAT THESE SYMPTOMS WERE NOT DEVICE RELATED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786331 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 523619 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention