BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 15848356 · Received November 22, 2022

    Report

    Report Number
    3006630150-2022-06469
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    September 8, 2022
    Report Date
    November 22, 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

    EVENT DATE: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. 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: 7062802. PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; SERIAL: N/A; BATCH: 26729873. PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; SERIAL: N/A; BATCH: 26729873.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION FROM THEIR DEEP BRAIN STIMULATION (DBS) LEADS. THE PHYSICIAN CONFIRMED WITH IMAGING TAKEN IN THE FIELD THAT THE DBS LEADS HAD RETRACTED 7MM FROM ITS INITIAL LEAD PLACEMENT. THE PHYSICIAN ASSESSED THAT THE BURR-HOLE COVER CLIPS DID NOT HOLD THE LEADS PROPERLY. THE PATIENT UNDERWENT A REVISION WHERE THE DBS LEADS, AND BURR-HOLE COVERS WERE REPLACED. THE DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247631 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2201-45-DC 5169189 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention