BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 2083839 · Received May 10, 2011

    Report

    Report Number
    2017865-2011-03617
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    February 9, 2011
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    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. RELIABILITY LABORATORY TECHNICIAN; (B)(4) FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND THE PROXIMAL RING ELECTRODE COVERED WITH MED-A AND A PROTECTIVE SLEEVE. THIS IS A WORKMANSHIP ANOMALY.

    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
    1 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1