BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

    MDR report key: 17523033 · Received August 12, 2023

    Report

    Report Number
    MW5129981
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Report Date
    March 1, 2019
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RV LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES SPIKES MEASURING GREATER THAN 2000 OHMS. HERE WAS NO SENSING ISSUES OBSERVED AND THE PATIENT DOESN'T RV PACE. TECHNICAL SERVICES (TS) RECOMMENDED EITHER CONTINUING TO MONITOR OR REPLACING THE RV LEAD. THE PHYSICIAN ELECTED TO CONTINUE TO MONITOR. NO 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
    2193010 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown