BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D, DF-4 CONNECTOR

    MDR report key: 4061841 · Received September 4, 2014

    Report

    Report Number
    2938836-2014-15517
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    July 5, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A VT STORM AND HAD RECEIVED SEVERAL HV SHOCKS. REVIEW OF THE EPISODE REVEALED INTERMITTENT UNDERSENSING ON THE VENTRICULAR CHANNEL. THE UNDERSENSING WAS NOT APPARENT ON THE OTHER EPISODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539944 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 74 YR