BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT IMPLANTABLE SLIM TIP LEAD, 50CM

    MDR report key: 19713981 · Received July 10, 2024

    Report

    Report Number
    1627487-2024-09631
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 10, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    PMP
    UDI-DI
    05415067027153
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS ESTIMATED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS.  BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: 50CM SLIMTIP IMPLANT LEAD KIT, ABT, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(6), BATCH: 9240018.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DECREASED THERAPY DUE TO FRACTURED LEAD. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION TO EXPLANT THE ENTIRE SYSTEM ON (B)(6) 2024. IT IS UNKNOWN WHICH LEAD FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040742 KIT IMPLANTABLE SLIM TIP LEAD, 50CM SCS LEAD PMP ABBOTT MEDICAL MN10450-50A 9240018 05415067027153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other DRG LEAD| SCS IPG