BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17517877 · Received August 11, 2023

    Report

    Report Number
    MW5124825
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    August 10, 2012
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    A CALL TO TECHNICAL SERVICES ON 7/10/2012 STATES THAT A MEDTRONIC LV LEAD WAS TURNED OFF DUE TO HIGH THRESHOLDS. NO OTHER INFORMATION IS AVAILABLE. 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
    2176688 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown