BEUDAMED
    FDA Adverse Event Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1896052 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04616
    Date Received
    November 10, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE HAD INCREASED. THE LEAD WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE ONE HARMONIC KNIFE DID NOT CONDUCT VIBRATIONS AT ALL. WHEN THE OTHER KNIFE WAS USED, THE LOWER SURFACE OF THE SHEATH WAS DAMAGED. ANOTHER LIKE DEVICE WAS USED. THERE WAS NO PT CONSEQUENCE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1