BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL QUADRA ASSURA

    MDR report key: 8080040 · Received November 15, 2018

    Report

    Report Number
    MW5081421
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 31, 2018
    Report Date
    November 2, 2018
    Manufacturer
    ST JUDE MEDICAL / ABBOTT LABORATORIES
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BATTERY HAD EARLY DEPLETION RESULTING IN EMERGENT GENERATOR CHANGE AS PT. HAD UNDERLYING SYMPTOMATIC BRADYCARDIA AROUND 40 BPM. HAD BEEN UNDER ADVISORY. DATES OF USE: (B)(6) 2014 - (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: BRADYCARDIA - BIV ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912418 ST JUDE MEDICAL QUADRA ASSURA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS ST JUDE MEDICAL / ABBOTT LABORATORIES 3365-40Q

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other