BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 15167477 · Received August 4, 2022

    Report

    Report Number
    3006630150-2022-03841
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    July 15, 2022
    Report Date
    August 4, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7088212; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7072222 AND 7072316; PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(4), BATCH: 511855; PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, LOT: 27414946, BATCH: 27414946.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT, WHO WAS IMPLANTED WITH A DEEP BRAIN STIMULATOR, HAD A SCAB LOCATED AT THE CONNECTOR SITE BEHIND THE EAR. UPON EXPLORATION, IT WAS NOTED BY SURGEON THAT THE CYLINDRICAL HUB ON THE LEAD EXTENSION HAD ERODED THROUGH THE SKIN. THE PATIENT UNDERWENT AN EXPLANT OF THE ENTIRE SYSTEM, AND WAS PLACED ON ANTIBIOTICS. THE PATIENT HAS FULLY RECOVERED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1381945 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7088288 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention