BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR

    MDR report key: 4220937 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17432
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE REPORTED FIELD EVENT OF AN INABILITY TO INTERROGATE THE DEVICE WAS NOT CONFIRMED IN THE LABORATORY. THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE OF THE RESET COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE AND COULD NOT BE INTERROGATED DESPITE SEVERAL ATTEMPTS. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703467 QUADRA ASSURA MP CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3371-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention