BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL STS

    MDR report key: 4121296 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07077
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 31, 2013
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    DTB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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. EVAL DESCRIPTION: FINAL ANALYSIS FOUND NORMAL DEVICE CHARACTERISTICS. NO ABNORMALITIES WERE NOTED ASIDE FROM DAMAGE SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED UNDERSENSING AND THE INSULATION HAD BEEN BREACHED DURING SUTURING. THE LEAD WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32547 TENDRIL STS PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION 2088TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1