BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 15238059 · Received August 16, 2022

    Report

    Report Number
    3006630150-2022-04108
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    June 9, 2022
    Report Date
    August 16, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    Adverse Event
    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-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; BATCH: 23861480. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(4); BATCH: 5147789. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(4); BATCH: 5150757.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED SCALP EROSION AT THE LEFT FRONTAL SCALP BURR HOLE SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156297 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-4600C 23746145 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| H