BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF4 CONNECTOR

    MDR report key: 3791098 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10385
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 1, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED IN CLINIC AFTER RECEIVING A VIBRATORY ALERT FOR NON-SUSTAINED LEAD NOISE. REVIEW OF EGMS REVEALED INTERMITTENT VENTRICULAR UNDERSENSING. PROGRAMMING CHANGES WERE RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268181 QUADRA ASSURA CRT-D, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3267-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR