BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1962652 · Received January 18, 2011

    Report

    Report Number
    2649622-2011-00062
    Event Type
    Death
    Date Received
    January 18, 2011
    Date of Event
    October 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    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.

    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 THAT THE PATIENT COLLAPSED AT A NEIGHBOR'S HOME. WHILE BEING TRANSPORTED TO THE HOSPITAL BY AMBULANCE, CPR WAS PERFORMED. THE PATIENT WAS PRONOUNCED DEAD AT THE HOSPITAL. A CHEST X-RAY INDICATED POSSIBLE PNEUMONIA. DEVICE RELATEDNESS AND CAUSE OF DEATH WAS REPORTED AS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COLLAPSED AT A NEIGHBOR'S HOME. WHILE BEING TRANSPORTED TO THE HOSPITAL BY AMBULANCE, CPR WAS PERFORMED. THE PATIENT WAS PRONOUNCED DIED AT THE HOSPITAL. A CHEST X-RAY INDICATED POSSIBLE PNEUMONIA. DEVICE RELATEDNESS AND CAUSE OF DEATH WAS REPORTED AS UNKNOWN. BASED ON FOLLOW-UP RECEIVED, THE CAUSE OF DEATH AND CIRCUMSTANCES SURROUNDING THE PATIENT'S DEATH IS UNKNOWN. MULTIPLE ATTEMPTS TO RETRIEVE DEATH INFORMATION WERE UNSUCCESSFUL.

    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 69 YR Death| H| L| R