BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL ST

    MDR report key: 4191765 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04611
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    March 13, 2012
    Manufacturer
    ST. JUDE MEDICAL, CRMD
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 DESCRIPTION: THE REPORTED FIELD EVENT WAS DISLODGEMENT AND HELIX NOT RETRACTING PROPERLY. THE INABILITY TO RETRACT HELIX WAS CONFIRMED. THE RETRACTION LENGTH WAS OUT OF SPECIFICATION DUE TO SOME STRETCHING OF THE HELIX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD DISLODGED THE HELIX WOULD NOT EXTEND OR RETRACT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28829 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, CRMD 1882TC/46

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention