BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19602377 · Received June 24, 2024

    Report

    Report Number
    1627487-2024-09481
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    May 28, 2024
    Report Date
    June 24, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MHY
    UDI-DI
    05415067020857
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. 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 COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: EXT, MODEL: 6372, UDI: (B)(4), SERIAL: (B)(6), BATCH: 6093960.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING HIGH IMPEDANCES ON 3 OF THE ELECTRODES. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE EXTENSION WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. NOTE : IT IS UNKNOWN WHICH EXTENSION IS RELATED TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103394 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B DBS EXTENSION MHY ABBOTT MEDICAL 6372 6093960 05415067020857

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other DBS BURR HOLEX2| DBS EXTENSION| DBS IPG| DBS LEADX2