BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL ST

    MDR report key: 4192175 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05458
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 30, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 DESCRIPTION: THE REPORTED FIELD EVENT OF HELIX WOULD NOT RETRACT WAS NOT CONFIRMED. ELECTRICAL ANALYSIS REVEALED SHORT CIRCUIT AND WAS USE TO DAMAGED INNER INSULATION INSIDE THE CONNECTOR PORTION AS A RESULT OF OVERTORQUE. OVERTORQUE OF INNER COIL PREVENTED THE STYLET INSERTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HELIX WOULD NOT RETRACT. AFTER REPOSITIONS OF LEAD, NOT A GOOD CAPTURE VOLTAGE WAS FOUND. THE PHYSICIAN DECIDED TO REMOVE THE LEAD. GUIDE WIRE WOULD NOT INSERT THROUGH THE LEAD. THE LEAD WAS CUT AND ANOTHER LEAD WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31433 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC., CRMD 1888TC/58

    Patients

    Seq Age Sex Outcome Treatment
    1