BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3080143 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00991
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    February 19, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 DURING FOLLOW-UP, HIGH CAPTURE THRESHOLD AND LOSS OF SENSING WERE NOTED. IT WAS NOTED THAT THE PATIENT IS PACEMAKER DEPENDENT. LEAD DISLODGEMENT WAS OBSERVED VIA FLUOROSCOPY. THE PHYSICIAN OPTED TO REPROGRAM THE DEVICE'S RV OUTPUT. THE PATIENT CONDITION IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182925 DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7170Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1