BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 18727621 · Received February 16, 2024

    Report

    Report Number
    3006630150-2024-00766
    Event Type
    Injury
    Date Received
    February 16, 2024
    Date of Event
    November 1, 2023
    Report Date
    February 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN NOVEMBER 2023 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6). BATCH: 7082023 PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12000 MODEL: DB-1200 SERIAL: (B)(6). BATCH: 746536

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A FEELING OF TENSION IN HER NECK. THE PHYSICIAN ASSESSED THE LEAD EXTENSIONS HAD BECOME TETHERED DUE TO SCAR TISSUE. THE PATIENT UNDERWENT A PROCEDURE TO RELEASE THE SCAR TISSUE, A SECOND PROCEDURE TO REVISE THE LEAD EXTENSIONS, AND A THIRD PROCEDURE TO REPOSITION THE IMPLANTABLE PULSE GENERATOR (IPG) HIGHER AND SUTURE DOWN. THE PATIENT DID WELL POSTOPERATIVELY. PHYSICAL ANALYSIS OF THE LEAD EXTENSIONS COULD NOT BE CONDUCTED IN OUR LABORATORY, AS THE DEVICES WERE CUT DURING THE PROCEDURE AND DISCARDED BY THE FACILITY; AND THE IPG REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451120 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7082084 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention