BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3901236 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12612
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 15, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(4). EVALUATION DESCRIPTION: A FRACTURE OF THE INNER COIL WAS FOUND AT THE CONNECTOR REGION CONSISTENT WITH FATIGUE. THIS FRACTURE IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE AND LEAD IMPEDANCE MEASUREMENT ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE. OUT OF RANGE AUTOCAPTURE MEASUREMENTS AND INCREASED PACING LEAD IMPEDANCE WERE ALSO NOTED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381124 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention 2088TC/46, CAT024324