BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D, DF-4 CONNECTOR

    MDR report key: 4130782 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16186
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 13, 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 Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING FOLLOW UP, AN ALERT FOR NON SUSTAINED RV OVERSENSING WAS OBSERVED. PROGRAMMING CHANGES WERE RECOMMENDED AND WILL BE MADE AT PATIENTS NEXT FOLLOW-UP. THE PATIENT WILL BE MONITORED UNTIL THEN. NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607639 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