BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021044 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-03947
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    January 18, 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 INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ALL INFORMATION KNOWN WAS PROVIDED PER THE COMPLAINANT. THEREFORE, NO ATTEMPTS FOR ADDITIONAL INFORMATION WILL BE MADE. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THE PROXIMAL CONDUCTOR HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, OUTER INSULATION BREACHED CUT, BLOOD IN/ON HELIX/LOBE MECHANISM, AND APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT DIED APPROXIMATELY TWO AND ONE HALF YEARS POST IMPLANT OF THE RIGHT VENTRICULAR (RV) LEAD WHICH WAS EXPLANTED. IT WAS ALSO NOTED THE PATIENT SUFFERED MENTAL ANGUISH AND EXTREME PHYSICAL INJURY.

    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 59 YR Death 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB