BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 6110222 · Received November 17, 2016

    Report

    Report Number
    2938836-2016-14337
    Event Type
    Death
    Date Received
    November 17, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN THE CLINIC CONTACTED THE PATIENT TO SCHEDULE A FOLLOW UP APPOINTMENT, THEY WERE TOLD BY THE PATIENT SPOUSE THAT THE PATIENT DIED AT HOME FROM MYOCARDIAL INFARCTION (MI). 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
    761659 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1688T/52 0002170905

    Patients

    Seq Age Sex Outcome Treatment
    1 Death (B)(4)| (B)(4)| (B)(4)