BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL STS

    MDR report key: 6014725 · Received October 10, 2016

    Report

    Report Number
    2017865-2016-06475
    Event Type
    Death
    Date Received
    October 10, 2016
    Date of Event
    September 10, 2016
    Report Date
    September 13, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST THE IMPLANT PROCEDURE, THE PATIENT WAS TAKEN BACK TO THE CATHETER LAB EXPERIENCING PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED THAT SAME MORNING. THE PATIENT DECEASED ON (B)(6) 2016. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS REPORTED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665916 TENDRIL STS PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 2088TC/52 P000030519

    Patients

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