BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION LEAD

    MDR report key: 3891015 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03634
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    February 7, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE STUDY FOLLOW-UP, THE ICD INDICATED AN ALERT FOR LOW IMPEDANCE FOR ONE-TIME. THE PHYSICIAN DID NOT MAKE ANY CHANGES AND WILL CHECK THE PATIENT IN THREE MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24269 DURATA STS OPTIM PASSIVE FIXATION LEAD DEFIBRILLATOR LEAD LWS LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D 7170/65

    Patients

    Seq Age Sex Outcome Treatment
    1