BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACEMAKER ASSURITY MRI

    MDR report key: 8760054 · Received July 2, 2019

    Report

    Report Number
    MW5087846
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    May 2, 2019
    Report Date
    July 1, 2019
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LEAD: ST. JUDE MEDICAL 2088 TC TENDRIL STS IMPLANTED WITH PACEMAKER: ST. JUDE 1272 ASSURITY MRI. LEAD FAILED SOME TIME IN THE FIRST 4 WEEKS AFTER IMPLANTATION, PACEMAKER IS NOW USELESS, BECAUSE LEAD IS NOT WORKING. HTTPS://PHARMAINTELLIGENCE.INFORMA.COM/RESOURCES/PRODUCT-CONTENT/HRS-2018-WRAP-UP. I FOUND THIS SITE; APPARENTLY TENDRIL LEADS HAVE A HIGHER FAILURE RATE. THIS WAS NOT DISCLOSED TO ME WHEN THE LEAD WAS SELECTED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545988 PACEMAKER ASSURITY MRI IMPLANTABLE PULSE GENERATOR PACEMALKER NON-CRT DTB ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION 1272
    545991 ST. JUDE MEDICAL 2088 TC TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL 2088

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other