BEUDAMED
    FDA Adverse Event Death Summary report: N

    TENDRIL SDX LEAD

    MDR report key: 6209263 · Received December 28, 2016

    Report

    Report Number
    2938836-2016-21954
    Event Type
    Death
    Date Received
    December 28, 2016
    Date of Event
    November 3, 2016
    Report Date
    November 29, 2016
    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 · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2016 FOR CHEST PAINS. THE PATIENT WAS RELEASED THE FOLLOWING DAY AND WAS TOLD TO COME BACK FOR A FOLLOW-UP IN 7-10 DAYS. THE PATIENT PASSED AWAY WITHIN 24 HOURS OF LEAVING THE HOSPITAL ON (B)(6) 2016. PREVIOUS NOTES STATED THAT THE PATIENT IS IN VT AND NEEDED TO DO NONINVASIVE PROGRAMMED STIMULATION (NIPS). THERAPY WAS DEACTIVATED, CHANGED THE VT ZONE AND THEN THERAPY WAS REACTIVATED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    859398 TENDRIL SDX LEAD PERMANENT PACEMAKER ELECTRODE NVN ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 1688TC/52 0002116262

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death (B)(4)| (B)(4)