BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENDRILL STS

    MDR report key: 4202297 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04957
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    March 3, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. THE REPORTED FIELD EVENT OF HELIX WOULD NOT EXTEND WAS CONFIRMED. THE HELIX WAS STUCK BECAUSE OF DRIED BODY FLUID INSIDE THE HELIX HOUSING. THIS IS CONSISTENT WITH DAMAGE SUSTAINED DURING THE SURGICAL PROCEDURE. THE OTHER REPORTED FIELD EVENTS OF LOSS OF CAPTURE, LOSS OF SENSING, AND HIGH LEAD IMPEDANCE WERE NOT CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT. THE LEAD HAD A LOSS OF CAPTURE AND SENSING, HIGH LEAD IMPEDANCE, AND A HELIX THAT WOULD NOT EXTEND. THE LEAD WAS EXPLANTED AND REPLACED. THE PT CONDITION AFTERWARDS WAS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28332 TENDRILL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 1688TC/46

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR