BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2770933 · Received October 3, 2012

    Report

    Report Number
    2649622-2012-12855
    Event Type
    Death
    Date Received
    October 3, 2012
    Date of Event
    March 7, 2009
    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 DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD COSMETIC DEPRESSION. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD COSMETIC DEPRESSION. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD COSMETIC DEPRESSION. THE DEVICE(S) ASSOCIATED WITH THIS ADVERSE OUTCOME WAS/WERE RETURNED FROM AN UNKNOWN SOURCE. CONSEQUENTLY, CONTACT INFORMATION TO COMPLETE FOLLOW-UP IS NOT REASONABLY KNOWN. THEREFORE, ATTEMPTS FOR ADDITIONAL INFORMATION CANNOT BE MADE. 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) SYSTEM WAS RETURNED FROM AN UNKNOWN SOURCE WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURER'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY SEVEN MONTHS POST IMPLANT OF THE CRT-D APPROXIMATELY THREE YEARS AGO.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death