BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION

    MDR report key: 1831174 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03539
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    June 28, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Product Problem
    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.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP, INCREASE IN VENTRICULAR LEAD IMPEDANCE AND DECREASE OF INTRINSIC SIGNAL WERE OBSERVED. A NEW FOLLOW-UP WILL BE SCHEDULED TO REVIEW THE MEASUREMENTS. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7170/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1