BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 20446754 · Received October 14, 2024

    Report

    Report Number
    3006630150-2024-06948
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    January 8, 2021
    Report Date
    October 14, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Product Problem
    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-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 1083388. PRODUCT FAMILY: DBS-IPG-R, UPN: M365DB1110C0, MODEL: DB-1110-C, SERIAL: (B)(6), BATCH: 19366508.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT HAD HIGH IMPEDANCES ON THE LEAD EXTENSIONS DURING AN ELECTIVE IMPLANTABLE PULSE GENERATOR (IPG) REPLACEMENT PROCEDURE. IT WAS NOTED THAT THE CONTACTS WITH HIGH IMPEDANCES WERE NOT USED FOR STIMULATION AND DID NOT AFFECT THERAPY PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2024 WHERE THE LEAD EXTENSIONS WERE REPLACED. PHYSICAL ANALYSIS OF THE LEAD EXTENSIONS WAS NOT PERFORMED AS THE DEVICES WERE DISPOSED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209078 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 19371612 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female