BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 1830649 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03367
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 1, 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
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED X-RAY ANALYSIS FOUND NO ANOMALIES TO THE DISTAL COIL AT STYLET RESTRICTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH THRESHOLDS WERE OBSERVED. A STYLET ANOMALY WAS OBSERVED DURING REPOSITION. THE LEAD WAS EXPLANTED WHEN REPOSITIONING WAS UNSUCCESSFUL.

    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 7120/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention 7120/60 (B)(4)