BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3791168 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10527
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    February 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T-WAVE OVERSENSING WAS OBSERVED VIA REMOTE TRANSMISSION. PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS REPROGRAMMED. NO FURTHER ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268369 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR