BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT DEFIBRILLATOR ELECTRODES

    MDR report key: 20095439 · Received August 27, 2024

    Report

    Report Number
    MW5158949
    Event Type
    Injury
    Date Received
    August 27, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEAD WAS EXPLANTED DUE TO PRODUCT PERFORMANCE ISSUE. THE LEAD IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314325 PERMANENT DEFIBRILLATOR ELECTRODES PERMANENT DEFIBRILLATOR ELECTRODES DTB BIOTRONIK, INC. 359067

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown