BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 6130439 · Received November 28, 2016

    Report

    Report Number
    2017865-2016-07376
    Event Type
    Death
    Date Received
    November 28, 2016
    Report Date
    November 7, 2016
    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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS DECEASED. 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
    779293 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 1688TC/52 3984894

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 1258T/86, (B)(4)| 2088TC/46, (B)(4)| PM3210, 2856222