BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021125 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-04043
    Event Type
    Death
    Date Received
    March 16, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. 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 FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. 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 FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY WAS MELTED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    ASKU

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT IS DECEASED.

    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 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB