BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3101112 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01896
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 22, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASIONS WERE FOUND AT 8.0-11.0CM AND 18.0-20.0CM FROM THE END OF THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE SILICONE INSULATION WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. EXTERNAL INSULATION ABRASIONS WERE FOUND AT 8.0-11.0CM AND 18.0-20.0CM FROM THE END OF THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE SILICONE INSULATION WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE RA LEAD EXPLANT PROCEDURE, AN INSULATION ANOMALY WAS OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203914 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention