BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 3101215 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-02041
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 25, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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

    NEW INFORMATION NOTES THAT SINCE THE PREVIOUS FOLLOW UP AFTER PROGRAMMING CHANGES WERE MADE, POST-PACED T-WAVE OVERSENSING WAS STILL OBSERVED. PATIENT WAS ASYMPTOMATIC. FURTHER PROGRAMMING CHANGES WERE RECOMMENDED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES ANOTHER INSTANCE OF NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T WAVE OVERSENSING WAS OBSERVED VIA REMOTE TRANSMISSION AFTER PROGRAMMING CHANGE WAS MADE. PATIENT WAS ASYMPTOMATIC. FURTHER PROGRAMMING CHANGES WERE RECOMMENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVED A VIBRATORY NOTIFIER FOR NONSUSTAINED LEAD NOISE EPISODE. CROSSTALK WAS OBSERVED. REPROGRAMMING WAS PERFORMED. THE PATIENT WILL BE MONITORED VIA (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204518 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 58 YR