BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 6131987 · Received November 29, 2016

    Report

    Report Number
    2938836-2016-14718
    Event Type
    Death
    Date Received
    November 29, 2016
    Report Date
    November 3, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT¿S DAUGHTER THAT THE PATIENT EXPIRED AS A RESULT OF ALLEGEDLY FAILED DEVICE. THE PATIENT HAD FOUR SMALL HEART ATTACKS THE DAY BEFORE HIS DEATH. THE DEVICE FUNCTIONED PROPERLY AND BROUGHT HIM OUT OF HIS ARRHYTHMIAS. HOWEVER, THE FOLLOWING DAY THE PATIENT HAD A MASSIVE HEART ATTACK AND WAS PRONOUNCED DEAD. THE MASSIVE HEART ATTACK WAS DUE TO SO MUCH FLUID BUILD-UP FROM THE PRIOR HEART ATTACKS. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783299 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 2088TC/52 3883795

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 1458Q/86, (B)(4)| 7121Q/65, (B)(4)| CD3265-40Q, (B)(4)