BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR

    MDR report key: 3884744 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12130
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 22, 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

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN RV OVERSENSING ALERT WAS OBSERVED DUE TO FUNCTIONAL UNDERSENSING OF A SLOW VT EVENT. THE PATIENT HAD SEVERAL EPISODES OF VT THAT WERE ALL TERMINATED WITH APT. THE LV PACING WAS PROGRAMMED OFF WHICH STOPPED THE VT EPISODES. FURTHER PROGRAM ADJUSTMENTS WERE MADE TO RESOLVE THE UNDERSENSING. THE PATIENT WAS STABLE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360667 UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3361-40QC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR