BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 19324151 · Received May 15, 2024

    Report

    Report Number
    3006630150-2024-03140
    Event Type
    Injury
    Date Received
    May 15, 2024
    Date of Event
    December 26, 2018
    Report Date
    May 15, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820758
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 5081305. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7028954.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DISCOMFORT IN HER RIGHT CHEST AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE WHEN SLEEPING ON HER SIDE. IT WAS NOTED THAT THE IPG WAS FLIPPING IN THE POCKET, AND AS A RESULT TUGGED ON THE EXTENSION WIRE IN THE NECK AND AT THE LEAD/EXTENSION CONNECTION BEHIND THE EAR. THE PATIENT UNDERWENT A PROCEDURE TO REVISE AND UPGRADE THE IPG. THE PATIENT DID WELL POSTOPERATIVELY. PHYSICAL ANALYSIS COULD NOT BE CONDUCTED BY OUR LABORATORY AS THE IPG WAS DISCARDED BY THE FACILITY, AND THE LEAD EXTENSIONS REMAIN IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670084 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1110-C 21606575 08714729820758

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention