BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1223747 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03521
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 16, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. THE DAMAGE FOUND WAS SUSTAINED DURING SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    PATIENT PRESENTED AT FOLLOW-UP WITH LOW SENSING AND DECREASE IN IMPEDANCES. X-RAY REVEALED THAT THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED.

    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 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention