BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA CRT-D

    MDR report key: 3781761 · Received April 30, 2014

    Report

    Report Number
    2938836-2014-10101
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    May 2, 2013
    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
    PA, US
    Reporter Occupation
    NURSE

    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 DURING FOLLOW UP, A STORED ALERT FOR HIGH, OUT OF RANGE HV LEAD IMPEDANCE WAS OBSERVED. POCKET ENCAPSULATION WAS SUSPECTED. SLIGHT DECREASE IN SENSING WAS ALSO NOTED. PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260751 QUADRA ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3265-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR