BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D

    MDR report key: 3892699 · Received June 24, 2014

    Report

    Report Number
    2938836-2014-12287
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    April 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ATP THERAPY DUE TO CROSSTALK OCCURRING AFTER AN ATRIAL PACED BEAT. RECOMMENDED PROGRAMMING CHANGES WERE MADE TO DEVICE. PATIENT CONDITION WAS FINE AND UNAWARE OF THE EVENT BEFORE AND AFTER REPROGRAMMING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368673 UNIFY QUADRA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3249-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention