BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1895650 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04470
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 15, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    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 AFTER THE DEVICE WAS INTERROGATED AT A FOLLOW-UP VISIT, REVIEW OF THE EGM NOTED NOISE ON THE RV LEAD. DEGRADATION OF THE LEAD INSULATION WAS SUSPECTED. THE PHYSICIAN OPTED TO MONITOR THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR