BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021124 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-04042
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    November 28, 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
    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) NO ANOMALIES FOUND, DISTAL CONDUCTOR AND SEVERAL CONDUCTORS DISTORTED, DEFIB CONDUCTOR FRACTURE (OVERSTRESS), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING KINKED/BUCKLED, INNER TUBING TORN, OUTER TUBING OVERLAY BREACHED CUT, OUTER INSULATION WHITE SUBSTANCE AND COSMETIC DEPRESSION, LEAD STRETCHED, APPARENT EXPLANT DAMAGE. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE LEAD HAD EXHIBITED A FRACTURED AND/OR WAS EXPLANTED. ADDITIONALLY, IT WAS ALLEGED THAT THE PATIENT "EXPERIENCED INAPPROPRIATE AND /OR EXCESSIVE SHOCKING" AND UNDEFINED "COMPLICATIONS," AND THE PATIENT IS DECEASED.

    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 THAT THE PATIENT "EXPERIENCED INAPPROPRIATE AND /OR EXCESSIVE SHOCKING" AND UNDEFINED "COMPLICATIONS," AND 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 55 YR Death| L 5076 IMPLANTABLE PACING LEAD| 7297 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 4193 IMPLANTABLE PACING LEAD| 7297 IMPLANTABLE PACEMAKER/CARDIO/DEFIB