BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 9110104 · Received September 24, 2019

    Report

    Report Number
    2938836-2019-13934
    Event Type
    Death
    Date Received
    September 24, 2019
    Report Date
    October 8, 2019
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR END MEASURING 12.6CM (OUTER COIL) WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT. FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. CONCOMITANT MEDICAL PRODUCTS: ACCENT DR RF PACEMAKER, TENDRIL SDX LEAD.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2019-14091, 2017865-2019-14092. IT WAS REPORTED THE PATIENT DECEASED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905159 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1488T/58 0002408026

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death