BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4130816 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16141
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    August 12, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FRACTURE OF THE RV AND SVC CONDUCTORS WERE NOTED UNDER THE STRAIN RELIEF COIL, CONSISTENT WITH FATIGUE. THESE FRACTURES ARE CONSISTENT WITH THE FIELD OBSERVATION OF A HIGH VOLTAGE LEAD IMPEDANCE ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED DUE TO FLUCTUATING HIGH VOLTAGE LEAD IMPEDANCE MEASUREMENTS. BOTH HIGH, OUT OF RANGE AND LOW, OUT OF RANGE VALUES WERE NOTED. THE LEAD WAS EXPLANTED. THE PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608492 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention