BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 3220144 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04606
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 3, 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
    IN
    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 WHEN THE ASYMPTOMATIC PATIENT PRESENTED IN-CLINIC AFTER RECEIVING A PATIENT NOTIFIER, POST-PACED T-WAVE OVERSENSING WAS OBSERVED. THE PATIENT DID NOT RECEIVE INAPPROPRIATE THERAPY. THE OVERSENSING WAS NOTED ON A STORED EGM. THE DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320186 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 82 YR