BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 19421398 · Received May 29, 2024

    Report

    Report Number
    3006630150-2024-03494
    Event Type
    Injury
    Date Received
    May 29, 2024
    Date of Event
    April 29, 2024
    Report Date
    May 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: M365DB3128550, MODEL: DB-3128-55, SERIAL: (B)(6), BATCH: 5002456.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENTS RIGHT LEAD DISPLAYED HIGH IMPEDANCES. THE NEUROLOGIST REPROGRAMMED HIS DEVICE USING THE OPEN CONTACTS AND THE PATIENT RECEIVED THERAPY. FOLLOWING THIS, AN X-RAY WAS TAKEN THAT SHOWED THAT THE LEAD HAD MIGRATED AT THE LEAD EXTENSION SITE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE RIGHT LEAD EXTENSION WAS REPOSITIONED AND RETIGHTENED. THE PHYSICIAN ASSESSED THAT THE EXTENSION HAD NOT BEEN PROPERLY TIGHTENED DURING THE INITIAL SURGERY. THE PATIENT IS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286254 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2201-45-DC 7074743

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention