BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR

    MDR report key: 1831189 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03525
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 1, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    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 ANALYSIS FOUND THAT THE LEAD WAS RETURNED IN TWO PIECES WITH MULTIPLE DAMAGES. A CRUSH OF THE INSULATION WAS FOUND AT 36-36.7 CM FROM THE HELIX END. THE INNER INSULATION AND THE ETFE INSULATIONS OF BOTH RV CABLES WERE DAMAGED. ELECTRICAL CONTINUITY OF THE LEAD PORTIONS WAS NORMAL. DUE TO THE CONDITION OF THE LEAD, NO FURTHER ANALYSIS COULD BE PERFORMED. THE LOCATION AND MODE OF THE DAMAGE ARE CONSISTENT WITH THAT PRODUCED BY CLAVICULAR CRUSH.

    Description of Event or Problem · 1

    THE PATIENT HAD AN ACCIDENT ON HER BICYCLE, SUFFERING TRAUMA TO THE IMPLANT SITE, RESULTING IN A MASSIVE HEMATOMA. SUB- SEQUENT CHECKS SHOWED A REDUCTION IN R-WAVE AMPLITUDE AND LEAD IMPEDANCE. THE PATIENT LATER RECEIVED AN INAPPROPRIATE SHOCK. DEVICE INTERROGATION REVEALED ONE EPISODE OF NOISE WITH ABORTED THERAPY, AND ONE EPISODE WITH THERAPY. DURING THE EXPLANT PROCEDURE, THERE WAS A COMPLETE FAILURE OF THE INSULATION AT AN AREA AROUND THE CLAVICLE-FIRST RIB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, SJ4 CONNECTOR DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention