BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 16422953 · Received February 22, 2023

    Report

    Report Number
    3006630150-2023-00772
    Event Type
    Injury
    Date Received
    February 22, 2023
    Date of Event
    January 28, 2023
    Report Date
    February 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7081511; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7080686.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION ON THEIR DEEP BRAIN STIMULATION (DBS) LEAD EXTENSION AREA. THE PHYSICIAN ASSESSED THERE WAS REDNESS AND INFLAMMATION AROUND THE LEAD EXTENSION AREA AND NOTED THE INFECTION WAS NOT TO BE DEVICE RELATED. THE PATIENT UNDERWENT A PROCEDURE AND HAD THE DBS LEAD EXTENSIONS AND IMPLANTABLE PULSE GENERATOR (IPG) REMOVED. CULTURES WERE TAKEN ALTHOUGH THE RESULTS ARE UNAVAILABLE. THE DEVICES WERE DISCARDED BY THE FACILITY AND WILL NOT RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119624 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 503521 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention