BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRIL SDX

    MDR report key: 4193537 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05530
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    June 1, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS DIFFICULT TO ADVANCE THROUGH THE SUBCLAVIAN TO SVC CATCHING ON THE IMPLANTED RV LEAD. DUE TO LACK OF SLACK THE LEAD DISLODGED AFTER THE LEAD HELIX WAS DEPLOYED. LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33723 TENDRIL SDX PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC. CRMD 1688TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR