BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 6435877 · Received March 23, 2017

    Report

    Report Number
    MW5068668
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    March 13, 2017
    Report Date
    March 23, 2017
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    GENERATOR CHANGE FOR RECALLED ST. JUDE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210712 ST. JUDE MEDICAL UNIFY QUADRA (RT-1) LWP ST. JUDE MEDICAL CD3249-40Q829430

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR