BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1670666 · Received April 30, 2010

    Report

    Report Number
    2649622-2010-01910
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    March 17, 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
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO T WAVE OVERSENSING (TWOS).IT WAS ALSO REPORTED THE PATIENT WAS UNCONSCIOUS. ADDITIONALLY, DURING THESE EPISODES, THE R WAVES WERE AT 1 MV AND THE T-WAVES WERE CONSIDERABLY BIGGER. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THAT THE PATIENT DIED AS OF (B) (6) 2010. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    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 68 YR Death