BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 4061834 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15494
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    May 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EPISODES OF AUTOMATIC MODE SWITCH WITH ATRIAL NOISE, AND NON-SUSTAINED RV LEAD NOISE EPISODES WERE OBSERVED. PATIENT RECEIVED A NOTIFICATION ALERT. FURTHER REVIEW OF THE EPISODES NOTED POSSIBLE MYOPOTENTIALS AND POTENTIAL ATRIAL LEAD DAMAGE. PROVOCATION TESTING WAS RECOMMENDED. SYSTEM REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541382 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3361-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR