BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1830650 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03368
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 3, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING MULTIPLE SHOCKS OVERNIGHT. IT WAS DETERMINED THAT THE RV LEAD HAD DISLODGED. A MAGNET WAS PLACED OVER THE DEVICE TO STOP THE INAPPROPRIATE SHOCKS; HOWEVER, THE PATIENT CONTINUED TO GET SHOCKED. THE LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE, IT WAS FOUND THAT THE LV AND THE RA LEAD WERE PULLED BACK ALL THE WAY INTO THE POCKET. THE RV WAS FOUND DISCONNECTED FROM THE ICD. ALL THREE LEADS WERE EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention