BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3911127 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12966
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 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 Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAD FRACTURE WAS OBSERVED. THE PATIENT HAD RECEIVED AN INAPPROPRIATE THERAPY DUE TO NOISE. PACING THRESHOLD, SENSING AND LEAD IMPEDANCE MEASUREMENTS HAD DECLINED SINCE IMPLANT. THE LEAD COMPLETELY FRACTURED LEAVING THE DISTAL PORTION OF THE LEAD IN THE HEART TISSUE. PATIENT CONDITION AFTER THE EVENT WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385981 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention