BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4153606 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16424
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 5, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NON-SUSTAINED RV OVERSENSING DUE TO LOSS OF CAPTURE WERE OBSERVED VIA REMOTE TRANSMISSION. PATIENT PRESENTED IN-CLINIC FOR FURTHER ASSESSMENT AND WAS SYMPTOMATIC WITH SHORTNESS OF BREATH. LOSS OF CAPTURE AND UNDERSENSING WERE OBSERVED. DUE TO THE PATIENT BEING A TWIDDLER ALL LEADS WERE DISLODGED. ALL THREE LEADS WERE EXPLANTED. THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632019 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention 1882TC/52, CWG033077, 1458Q/86, BPP034577