BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 4092132 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05036
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 28, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION: THE REPORTED HELIX ANOMALY WAS CONFIRMED IN THE LABORATORY. AS RECEIVED, THE LEAD PACKAGE WAS FOUND NOT OPENED AND REMAINED INSIDE THE ORIGINAL CASING. THE LEAD WAS VISUALLY INSPECTED AND NOTED THAT THE HELIX WAS PARTIALLY EXTENDED. THE HELIX EXTENSION EXCEEDED THE NORMAL PRODUCT SPECIFICATION. NO OTHER ANOMALIES WERE FOUND. THIS CONDITION IS INDICATIVE OF A POTENTIAL MANUFACTURING ISSUE. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THE FIELD RETURN CONDITION AND REMEDIAL TRAINING ACTIONS HAVE BEEN TAKEN TO MITIGATE THE OCCURRENCE OF THIS CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HELIX WAS FOUND EXTENDED WHILE IN PACKAGE. THE LEAD WAS NOT USED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22715 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7120Q/58

    Patients

    Seq Age Sex Outcome Treatment
    1