BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1850497 · Received October 1, 2010

    Report

    Report Number
    2649622-2010-09083
    Event Type
    Death
    Date Received
    October 1, 2010
    Date of Event
    September 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A RED ALERT TRANSMISSION FOR AN LIA (LEAD INTEGRITY ALERT) TRIPPED. THERE WERE 3 NONSUSTAINED TACHYCARDIAS WITH AVERAGE RATES OF 286, 316, AND 333 BEATS PER MINUTE. THE CURRENT EGM IS SHOWING NO RHYTHM, BUT APPARENT VENTRICULAR OVERSENSING. THERE IS NO RIGHT VENTRICULAR EGM TO SEE IF SENSING IS APPROPRIATE, "THOUGH THERE ARE NO A OR LV COMPLEXES." THE NURSE SPECULATED THAT THE PATIENT DIED, SHE HAD BEEN VERY SICK WITH CANCER AND WAS POSSIBLY ON HOSPICE. FOLLOW UP REVEALED THE PATIENT DID NOT WANT HER DEVICE TURNED OFF AND THE ALERT SOUNDED "BECAUSE THE PATIENT DIED." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6949 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death 4193 IMPLANTABLE PACING LEAD| 5568 IMPLANTABLE PACING LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB