BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3872936 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11873
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 1, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE DUE TO NORMAL ERI. TWO YEARS PRIOR AN ALERT FOR LOW, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE HAD BEEN RECEIVED BUT NO ACTION WAS TAKEN AS THE PATIENT WAS LOST TO FOLLOW-UP. AN ALERT FOR LOW, OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE WAS NOTED DURING DFT TESTING WITH THE NEW DEVICE. THE VECTOR WAS REPROGRAMMED TO EXCLUDE THE SVC COIL AND THE IMPEDANCES MEASURED NORMALLY. LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349178 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR