BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY QUADRA CRT-D, DF4 CONNECTOR

    MDR report key: 3781749 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-09970
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    March 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 A SENSED VENTRICULAR EVENT WAS MARKED INAPPROPRIATELY DURING A PACED ATRIAL EVENT ON THE STORED ELECTROGRAM. NO CHANGES WERE MADE TO THE DEVICE. THE PATIENT IS SCHEDULED FOR FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259620 UNIFY QUADRA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3249-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR