BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3220217 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04331
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 1, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE PATIENT PRESENTED TO THE ER DUE TO THE PATIENT NOTIFIER ALERT. INCREASED PACING LEAD IMPEDANCE MEASUREMENT WAS OBSERVED. NO NOISE WAS NOTED DURING ISOMETRIC TESTING. NO OTHER ELECTRICAL ANOMALIES WERE NOTED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319842 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7121Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention