BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 6066265 · Received October 31, 2016

    Report

    Report Number
    2938836-2016-13457
    Event Type
    Death
    Date Received
    October 31, 2016
    Date of Event
    July 7, 2016
    Report Date
    October 24, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    T WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) WITH CHEST PAIN AND SHORTNESS OF BREATH. UPON REVIEWING THE PATIENT, INFECTION/ENDOCARDITIS RELATED TO THE INFECTED LEAD WAS NOTED. THE PATIENT WAS TRANSFERRED AFTER THE EXPLANT. FURTHER FOLLOW UP REVEALED THAT THE PATIENT EXPIRED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718158 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1688TC/46 0002108035

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death 1156T/86, (B)(4)| 7022/65, (B)(4)| CD3257-40, 7010307