BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION LEAD

    MDR report key: 3891027 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03635
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    July 19, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PARTIAL LEAD MEASURING 75.5CM WAS RETURNED. THE LEAD WAS CUT AND DAMAGED IN THE FIELD AND ONLY PACING COIL WITH THE DISTAL TIP WAS RETURNED. THE APPEARANCE OF THE TIP OF THE LEAD INDICATED THAT THE TIP HAD BEEN MECHANICALLY DAMAGED. HOWEVER AS THE ENTIRE LEAD WAS NOT RETURNED A COMPLETE MATERIAL ANALYSIS WAS NOT POSSIBLE TO CARRY OUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT THE RV LEAD WAS BROKEN INTO TWO PARTS. THE LEAD WAS NOT IMPLANTED AND RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24271 DURATA STS OPTIM PASSIVE FIXATION LEAD DEFIBRILLATION LEAD, LWS LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7170/65

    Patients

    Seq Age Sex Outcome Treatment
    1