BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1831209 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03502
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 4, 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 Location
    VA
    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 A DEVICE UPGRADE, THE OLD PACE/SENSE LEAD WAS EXAMINED AND NOTED TO HAVE AN INSULATION BREAK. HENCE, IT WAS CAPPED. THE PHYSICIAN THEN TRIED TO USE THE RV LEAD AS THE PACE/SENSE BUT WERE FOUND TO HAVE LOW R-WAVES. LEAD REPOSITIONING WAS ATTEMPTED, HOWEVER, SENSING WAS INADEQUATE. HENCE, THE LEAD WAS CAPPED.

    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 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention