BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3090113 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01116
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 6, 2013
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO IMPLANT PROCEDURE, THE PHYSICIAN BELIEVED THAT THE LEAD SHAPE WAS NOT NORMAL. DURING IMPLANT PROCEDURE, VERY LOW SENSING VALUES WERE NOTED. SEVERAL ATTEMPTS WERE MADE TO POSITION THE LEAD BUT WERE UNSUCCESSFUL. A NEW LEAD WAS IMPLANTED. THE PATIENT'S CONDITION WAS GOOD AFTER THE PROCEDURE. THE LEAD WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191566 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1