BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 16199781 · Received January 18, 2023

    Report

    Report Number
    3006630150-2023-00120
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 28, 2022
    Report Date
    January 18, 2023
    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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7097567. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12160, MODEL: DB-1216, SERIAL: (B)(4), BATCH: 535804. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7091873.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AT THE DEEP BRAIN STIMULATION (DBS) LEAD EXTENSION INCISION SITE. THE PHYSICIAN'S ASSESSMENT WAS THOUGHT TO BELIEVE THE INFECTION WAS CAUSED BY IMPAIRED HEALING. CULTURES WERE TAKEN ALTHOUGH THE RESULTS ARE UNAVAILABLE. THE PATIENT UNDERWENT A PROCEDURE WHERE ALL THE DBS DEVICES WERE REMOVED. THE DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT RETURN FOR ANALYSIS. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925114 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7097499 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention