BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL ST

    MDR report key: 6135018 · Received November 30, 2016

    Report

    Report Number
    2938836-2016-14784
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    August 14, 2016
    Report Date
    October 20, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVN
    PMA / PMN Number
    P960013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEAD WAS RETURNED FOR EVALUATION AFTER THE PATIENT WAS REPORTED TO HAVE DECEASED. A COMPLETE LEAD WAS RETURNED IN TWO PIECES. VISUAL INSPECTION OF THE LEAD FOUND NO ANOMALIES EXCEPT FOR DAMAGES CONSISTENT WITH PROCEDURE DAMAGE. ELECTRICAL TESTING DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS HEART DISEASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787010 TENDRIL ST PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1888TC/52 2798186

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death 7120Q/58, BJP25742.| CD2231-40Q, 597887.| 7120Q/58, BJP25742| CD2231-40Q, 597887