BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3791145 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10432
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO PACING WAS OBSERVED DURING IMPLANT ON THE RV LEAD THROUGH THE ANALYZER OR WHEN CONNECTED TO THE DEVICE. HIGH, OUT OF RANGE PACING IMPEDANCE WAS ALSO OBSERVED WHEN THE LEAD WAS CONNECTED TO THE DEVICE. A NEW SYSTEM WAS IMPLANTED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269240 DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7172Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR (B)(4)