BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA DR CRT-D

    MDR report key: 4021807 · Received August 19, 2014

    Report

    Report Number
    2938836-2014-14524
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    June 23, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED LEAD NOISE DUE TO POST-PACED T WAVE OVERSENSING WAS OBSERVED. THE PHYSICIAN ELECTED NOT TO MAKE ANY PROGRAMMING CHANGES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED INDICATES THAT EPISODES OF NON-SUSTAINED RV OVERSENSING DUE TO ANOTHER CASE OF POST-PACED T-WAVE OVERSENSING WAS OBSERVED. THE PHYSICIAN ELECTED TO TAKE NO ACTION OTHER THAN TO TURN ON THE NON-SUSTAINED RV OVERSENSING PATIENT NOTIFIER. THE PATIENT WAS IN GOOD CONDITION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN MADE THE PROGRAMMING CHANGES TO AVOID NON-SUSTAINED OVERSENSING EPISODES. THE PATIENT WAS IN A GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499509 UNIFY ASSURA DR CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3361-40C NA

    Patients

    Seq Age Sex Outcome Treatment
    1