BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021009 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-03926
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    October 25, 2009
    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
    TX, 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 THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, OUTER TUBING OVERLAY BREACHED CUT, OUTER INSULATION COSMETIC DEPRESSION, BLOOD IN/ON HELIX/LOBE MECHANISM, AND APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICTED THE PATIENT RECEIVED A SERIES OF UNNECESSARY ELECTRICAL SHOCKS DUE TO A DEFECT AND/OR FAILURE OF THE LEAD AND UNDERWENT SURGICAL PROCEDURES FOR PROMPT REMOVAL OF THE DEFECTIVE LEAD. APPROXIMATELY, THREE YEARS AFTER THE FIRST ALLEGATION, AN ALLEGATION FROM THE SAME ATTORNEY INDICATED THE PATIENT IS DECEASED AND FURTHER INDICATED THAT THE LEAD HAD EXHIBITED A FRACTURE AND/OR WAS EXPLANTED.

    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 49 YR Death| H| L| R 7304 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 6996 IMPLANTABLE TACHY LEAD| 5524 IMPLANTABLE PACING LEAD