BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION LEAD

    MDR report key: 3890366 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-03633
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    October 11, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 OT THE REPORTING CRITERIA GOING FORWARD. EVALUATION DESCRIPTION INCLUDED. THE COMPLAINT COULD NOT BE VERIFIED. NORMAL OILS CONTINUITY AND NORMAL INSULATION RESISTANCE WAS MEASURE FOR THE RETURNED PART. SINCE THE ENTIRE LEAD WAS NOT RETURNED, A COMPLETE ANALYSIS COULD NOT BE PERFORMED. THE LEAD WAS CUT IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN DETECTED HIGH PACING ON THE RV LEAD. THE LEAD WAS REPLACED AND PARTIALLY RETURNED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28089 DURATA STS OPTIM PASSIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST. JUDE MEDICAL INC., CRMD 7170/65

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention