BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 20079706 · Received August 23, 2024

    Report

    Report Number
    MW5158880
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Report Date
    August 6, 2024
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    LWS
    Product Problem
    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
    1520446 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BIOTRONIK, INC. 393032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown