BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17516506 · Received August 11, 2023

    Report

    Report Number
    MW5123455
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    June 3, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    TECHNICAL SERVICES RECEIVED A CALL ON 05/12/2011 FROM SALES REP. STATUS SYMBOL IN THIS CASE IS ESSENTIALLY AN "FYI," R WAVES ARE CONSISTENTLY GREATER THAN 25MV. 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
    762378 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown