BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3457173 · Received November 7, 2013

    Report

    Report Number
    2938836-2013-08450
    Event Type
    Malfunction
    Date Received
    November 7, 2013
    Date of Event
    August 22, 2013
    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
    PA, 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 DURING THE IMPLANT PROCEDURE, DFT TESTING WAS UNSUCCESSFUL. THE RV LEAD WAS PLACED WITHOUT COMPLICATIONS AND ELECTRICAL MEASUREMENTS WERE NORMAL. THE PATIENT HAD TO BE EXTERNALLY RESCUED TWICE AFTER FAILED DFT TESTS. IT WAS MENTIONED THAT THE PATIENT HAD AN EJECTION FRACTION OF 15 PERCENT. THE PHYSICIAN DECIDED TO DELAY FURTHER DFT TESTING AND SET THE DEVICE TO MAXIMUM HV OUTPUT. THE PATIENT WILL HAVE ONE OR TWO MONTHS OF BIV PACING WITH THE GOAL OF IMPROVING THE EJECTION FRACTION BEFORE DFT TESTING. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574537 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR