BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3801314 · Received May 8, 2014

    Report

    Report Number
    2938836-2014-10992
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    March 9, 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
    FL, 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 PATIENT CAME TO THE ER UPON RECEIVING AN ALERT FOR NON-SUSTAINED LEAD NOISE. POST-PACED T-WAVE OVERSENSING WAS SUSPECTED. LATENCY BETWEEN THE NEAR FIELD AND FAR FIELD CHANNEL CAUSED THE NON-SUSTAINED LEAD NOISE ALERT. THE ISSUE WAS RESOLVED THROUGH REPROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279057 QUADRA ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR