BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021165 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-04026
    Event Type
    Death
    Date Received
    March 16, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S030
    Removal / Correction Number
    Z-0069-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4):THE FULL LEAD WAS RETURNED, ANALYZED AND TH PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT ALL CONDUCTORS DISTORTED, THE DEFIBRILLATION CONDUCTOR FRACTURED DUE TO OVERSTRESS, THE OUTER INSULATION WAS KINKED/BUCKLED, OUTER TUBING OVERLAY WITH COSMETIC ENVIRONMENTAL STRESS CRACK, THE OUTER TUBING HAD COSMETIC ENVIRONMENTAL STRESS CRACK BREACH (NON ELECTRICAL), THE OUTER INSULATION WAS TORN, OUTER TUBING OVERLAY WAS BREACHED CUT AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE PATIENT IS INVOLVED IN A SETTLEMENT INVOLVING THE (B)(4). 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 FULL LEAD WAS RETURNED, ANALYZED AND TH PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT ALL CONDUCTORS DISTORTED, THE DEFIBRILLATION CONDUCTOR FRACTURED DUE TO OVERSTRESS, THE OUTER INSULATION WAS KINKED/BUCKLED, OUTER TUBING OVERLAY WITH COSMETIC ENVIRONMENTAL STRESS CRACK, THE OUTER TUBING HAD COSMETIC ENVIRONMENTAL STRESS CRACK BREACH (NON ELECTRICAL), THE OUTER INSULATION WAS TORN, OUTER TUBING OVERLAY WAS BREACHED CUT AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE PATIENT IS INVOLVED IN A SETTLEMENT INVOLVING THE SPRINT FIDELIS LEADS. 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

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE LEAD HAD EXHIBITED A FRACTURE AND/OR WAS EXPLANTED. ADDITIONALLY IT WAS ALLEGED THE PATIENT IS DECEASED.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT FIDELIS IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6948 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6944 IMPLANTABLE TACHY LEAD| 4592 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4196 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD| 4196 IMPLANTABLE PACING LEAD