BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021031 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-03937
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    November 15, 2008
    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
    CA, 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 IN SEGMENTS WERE RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THE DEFIB CONDUCTOR WAS DISTORTED, DEFIB CONDUCTOR FRACTURE (OVERSTRESS), OUTER TUBING KINKED/BUCKLED, OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING, OUTER TUBING ENVIRONMENTAL STRESS CRACKING BREACH/BREACH (NON-ELECTRICAL), OUTER INSULATION COSMETIC DEPRESSION, BLOOD IN/ON HELIX/LOBE MECHANISM, LEAD STRETCHED, AND APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD. THE PATIENT EXPERIENCED INAPPROPRIATE AND/OR EXCESSIVE SHOCKING, FRACTURE OR OTHER INJURY REQUIRING MEDICAL INTERVENTION INCLUDING BUT NOT LIMITED TO SURGERY, REMOVAL AND/OR REPLACEMENT OF THE DEFECTIVE LEAD. THE PATIENT HAS SUSTAINED SEVERE PHYSICAL INJURIES AND/OR DEATH. THE PATIENT "DIED AS A DIRECT AND PROXIMATE RESULT OF DEFECTS" IN THE LEAD. APPROXIMATELY TWO YEARS AFTER THE FIRST ATTORNEY'S ALLEGATION, THERE IS AN ALLEGATION FROM A SECOND ATTORNEY THAT 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 46 YR Death| H| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB