BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 5994054 · Received October 3, 2016

    Report

    Report Number
    2938836-2016-12092
    Event Type
    Death
    Date Received
    October 3, 2016
    Date of Event
    September 5, 2016
    Report Date
    June 29, 2017
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 10.0 CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT FELL AT HOME ON (B)(6) 2016 AND FRACTURED HER HEEL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND LATER TRANSFERRED TO CARE FACILITY FOR REHAB. THE PATIENT WAS FOUND FACE DOWN AND TRIED TO REVIVE BUT WERE UNABLE TO DO SO. PER THE PATIENT'S HUSBAND, THE CORONER SAID THE DEATH WAS RELATED TO HER HEART AND NO AUTOPSY WOULD BE PERFORMED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646786 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 2088TC/46 P000012173

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death (B)(4)