BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 3791110 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10460
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 27, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALERT FOR NON-SUSTAINED LEAD NOISE AND PRESENTED IN THE CLINIC. POST-PACED T-WAVE OVERSENSING WAS OBSERVED ON THE VENTRICULAR LEAD VIA STORED EGM. PATIENT WAS ASYMPTOMATIC. THE ICD WAS REPROGRAMMED. THE PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268185 QUADRA ASSURA CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3365-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR