BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRENDRIL STS

    MDR report key: 4191973 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04622
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 2, 2011
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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: FINAL ANALYSIS COULD NOT CONFIRM THE COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THRESHOLDS DIMINISHED AFTER BEING SUTURED INTO THE TISSUE. THE LEAD WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29800 TRENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CRMD 2088TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR