BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2120387 · Received June 10, 2011

    Report

    Report Number
    2649622-2011-07779
    Event Type
    Death
    Date Received
    June 10, 2011
    Date of Event
    March 18, 2011
    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
    MN, US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY : (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND FOUND TO HAVE NO ANOMALIES. (B)(4) NO ANOMALIES FOUND, DEFIB CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), PROXIMAL CONDUCTOR BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER TUBING OVERLAY COSMETIC ESC, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEADS IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND FOUND TO HAVE NO ANOMALIES. 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

    A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND TWO LEADS WERE RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY FOUR MONTHS POST THE IMPLANT OF THE CRT-D SYSTEM. CAUSE OF DEATH WAS 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 88 YR Death