BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2181923 · Received July 28, 2011

    Report

    Report Number
    2649622-2011-10885
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    April 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED, THE DEFIBRILLATION COIL WAS FRACTURED, THE DEFIBRILLATION COIL WAS DISTORTED, THE DEFIBRILLATION CONDUCTOR WAS FRACTURED (OVERSTRESS), OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, OUTER TUBING ENVIRONMENTAL STRESS CRACKING BREACH (NON-ELECTRICAL), THE OUTER INSULATION WAS TORN, EXPOSED DEFIB COIL WHITE SUBSTANCE AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. A BILUMEN TUBING VOID (NON-ELECTRICAL) WAS ALSO NOTED AT 60CM.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED, THE DEFIBRILLATION COIL WAS DISTORTED, THE DEFIBRILATION CONDUCTOR WAS FRACTURED (OVERSTRESS), OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, OUTER TUBING ENVIRONMENTAL STRESS CRACKING BREACH (NON-ELECTRICAL), THE OUTER INSULATION WAS TORN, EXPOSED DEFIB COIL WHITE SUBSTANCE AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. A BILUMEN TUBING VOID (NON-ELECTRICAL) WAS ALSO NOTED AT 60CM.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED WITH NO INFORMATION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATIONS. A DATABASE SEARCH REVEALED THE PATIENT HAD EXPIRED. FOLLOW UP WAS ATTEMPTED AND HAS BEEN INCONCLUSIVE SO FAR. ADDTIONAL INFORMATION HAS BEEN REQUESTED AND NOT YET RECIEVED. NO COMPLAINTS OR ALLEGATIONS HAVE BEEN MADE AGAINST THE LEAD.

    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| O 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB