BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 20476910 · Received October 17, 2024

    Report

    Report Number
    3006630150-2024-07075
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    May 1, 2024
    Report Date
    October 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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: 7071893. PRODUCT FAMILY: DBS-IPG-R-MRI: UPN: M365DB1200S0. MODEL: DB-1200-S. SERIAL: (B)(6). BATCH: 740374. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 5179937. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7071251. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: NULL. BATCH: 24474551. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: NULL. BATCH: 25076117.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) INFECTION AND EROSION IN THE SCALP WHERE THE LEAD AND LEAD EXTENSION MEET. THE EROSION WAS NOTED IN THE SCALP AREA AND THE INFECTION WAS NOTED TO HAVE TRAVELED DOWN FROM THE SCALP AREA INTO THE CHEST POCKET WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT A FULL SYSTEM EXPLANT WHERE THE LEAD EXTENSIONS, LEADS, IPG, AND BURR HOLE COVERS WERE REMOVED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS EXPECTED TO FULLY RECOVER POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1463047 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7072343 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Hospitalization| R