BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 13389662 · Received January 28, 2022

    Report

    Report Number
    3006630150-2022-00246
    Event Type
    Injury
    Date Received
    January 28, 2022
    Date of Event
    October 29, 2019
    Report Date
    January 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729836544
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220145DC0, MODEL: DB-2201-45-DC, SERIAL: (B)(4), BATCH: 5168274.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD NEVER RECEIVED ADEQUATE STIMULATION FOR HER LEFT HAND. MAGNETIC RESONANCE IMAGING (MRI) AND A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS TAKEN IN THE FIELD, AND REVEALED THE LEADS HAD MIGRATED. THE PHYSICIAN CONFIRMED THE DAY AFTER THE ORIGINAL STAGE I IMPLANT PROCEDURE THAT THE LEADS WERE IN PLACE. HOWEVER, THE STAGE II PROCEDURE OCCURRED TWO WEEKS LATER AND THE PHYSICIAN COULD NOT CONFIRM IF THE LEADS HAD MIGRATED AT THAT TIME. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS WERE REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860246 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2201-45-DC 5148976 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention