BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8CH INFINITY DBS FLEX EXTN KIT, 60CM, B

    MDR report key: 19455687 · Received June 3, 2024

    Report

    Report Number
    1627487-2024-09144
    Event Type
    Injury
    Date Received
    June 3, 2024
    Date of Event
    May 15, 2024
    Report Date
    June 8, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067020857
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PATIENT EXPERIENCING INEFFECTIVE THERAPY WAS REPORTED TO ABBOTT. THE PATIENT HAS BEEN PROGRAMMED OVER THE YEARS WITH LITTLE BENEFIT. THE PATIENT HAD TWO COMPLETE SYSTEMS (2 IPGS, 4 EXTENSIONS, 4 LEADS) EXPLANTED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION RECEIVED, A SINGLE DEFINITIVE ROOT CAUSE FOR THE ISSUE ENCOUNTERED WAS UNABLE TO BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 0

    SECTION B3: DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 2 EXTENSIONS; HOWEVER, IT IS UNKNOWN WHICH EXTENSION, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: DBS EXTENSION, MODEL: 6372, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6922087.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INEFFECTIVE THERAPY FOR TOURETTE¿S SYNDROME. REPROGRAMMING WAS ATTEMPTED TO NO AVAIL. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659580 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B SCS EXTENSION MHY ABBOTT MEDICAL 6372 6900425 05415067020857

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Other DBS EXTENSION (1)| DBS IPG (1)| DBS LEAD (1)