BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3791106 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10463
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 13, 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
    CA, US
    Reporter Occupation
    OTHER

    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 PRIOR TO IMPLANT, THE DEVICE WOULD NOT SWITCH AND PICK UP RF TELEMETRY WHILE STILL IN THE BOX. SEVERAL ATTEMPTS ON OBTAINING TELEMETRY WERE UNSUCCESSFUL. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269204 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR