BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 8702450 · Received June 16, 2019

    Report

    Report Number
    2017865-2019-09658
    Event Type
    Malfunction
    Date Received
    June 16, 2019
    Date of Event
    June 3, 2019
    Report Date
    June 16, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    LWS
    UDI-DI
    05414734502122
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE EVENT WAS OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THE COMPLETE LEAD WAS RETURNED IN TWO PIECES. THE CONNECTOR PORTION WAS 12.4 CM AND THE DISTAL PORTION WAS 56.6 CM. EXTERNAL ABRASION BREACHING THE OPTIM SHEATH WAS FOUND AT 10.5 ¿ 10.6 CM FROM THE CONNECTOR PIN. THE CAUSE OF EXTERNAL ABRASION WAS CONSISTENT WITH FRICTION TO THE PULSE GENERATOR CAN.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495893 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 7121/65 3267604 05414734502122

    Patients

    Seq Age Sex Outcome Treatment
    1