BEUDAMED
    FDA Adverse Event Other Summary report: N

    DEFIBRILLATION LEAD

    MDR report key: 18048811 · Received October 31, 2023

    Report

    Report Number
    MW5147596
    Event Type
    Other
    Date Received
    October 31, 2023
    Report Date
    October 16, 2023
    Manufacturer
    ST. JUDE / ABBOTT MEDICAL
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    Q: WHY ISN'T THE SVC(STATIC VAR COMPENSATOR) WORKING ON THIS SJM(ST. JUDE MEDICAL) 7120 LEAD? WE ARE IN A CASE DOING A COMPETITIVE CHANGE OUT. D: CALLER DID NOT PROVIDE- ASKED UNKNOWN R: REFERRED CALLER TO SJM/ABBOTT TECHNICAL SERVICES FOR SERIAL NUMBER SPECIFIC CALLS ABOUT THIS PATIENTS LEAD INTEGRITY. SUGGESTED CALLER CHECK CONNECTION AND MAKE SURE THE SVC IS IN SVC DEDICATED PORT, RV HV IS IN RV HV DEDICATED PORT AND P/S PORTION IN P/S PORTION OF THE HEADER AND CHECK DEVICE AGAIN FOR IMPEDANCE VALUES. 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
    2112738 DEFIBRILLATION LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST. JUDE / ABBOTT MEDICAL 7120

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown