BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 3210749 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03478
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 19, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING A PATIENT NOTIFIER FOR NON-SUSTAINED LEAD NOISE. OVERSENSING WAS NOTED ON NONSUSTAINED LEAD NOISE SEGM AND WAS DUE TO CROSSTALK. REPROGRAMMING WAS PERFORMED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310542 QUADRA ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3265-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR