BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4221085 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17386
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    August 28, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 A MERLIN.NET TRANSMISSION SHOWED OVERSENSING DUE TO NOISE ON THE RV LEAD. FURTHER TESTING WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702897 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR