BEUDAMED
    FDA Adverse Event Death Summary report: N

    6949 SPRINT FIDELIS

    MDR report key: 1964285 · Received January 19, 2011

    Report

    Report Number
    2649622-2011-00068
    Event Type
    Death
    Date Received
    January 19, 2011
    Date of Event
    November 17, 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
    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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND.

    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) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND, OUTER TUBING OVERLAY COSMETIC ESC, OUTER INSULATION COSMETIC DEPRESSION. PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 1

    ASKU

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS NOTED PATIENT DIED LESS THAN ONE YEAR AFTER DEVICE IMPLANT. FOLLOW UP WITH THE CLINIC REPORTED THE CAUSE OF DEATH WAS THYROID CANCER WITH METASTASIS TO THE LUNGS. THE LAST DEVICE CARDIOLOGY VISIT HAD BEEN 22 DAYS PRIOR TO THE PATIENT DEATH WITH NORMAL DEVICE FUNCTIONS NOTED. REPORTED THE DEATH WAS NOT RELATED TO THE DEVICE OR LEAD SYSTEM. IT WAS UNKNOWN IF AN AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    IT WAS NOTED PATIENT DIED LESS THAN ONE YEAR AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ASKU

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death