BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3791079 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10429
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    March 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PACER-DEPENDENT PATIENT PRESENTED IN THE ER AFTER EXPERIENCING A SYNCOPE EPISODE. UPON DEVICE CHECK, INHIBITED PACING DUE TO OVERSENSING WAS OBSERVED. THE PHYSICIAN SUSPECTED CLAVICULAR CRUSH DUE TO A LARGE NUMBER OF LEADS IN THE SUBCLAVIAN MAY HAVE CONTRIBUTED TO THE OVERSENSING. THE DEVICE WAS DOWNGRADED TO A PACEMAKER AND THE LEAD WAS CAPPED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269174 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention