BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1876050 · Received October 20, 2010

    Report

    Report Number
    2649622-2010-11934
    Event Type
    Death
    Date Received
    October 20, 2010
    Date of Event
    March 27, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT INVOLVES A LEGAL CASE IN PROGRESS OR POTENTIAL LITIGATION. THE PROPRIETARY NATURE OF THE EVENT MAY AFFECT FOLLOW UP EFFORTS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. OUR RECORDS INDICATE THE PATIENT EXPIRED MORE THAN ONE YEAR AGO. WE HAVE NO INFORMATION FROM A HEALTH CARE PROFESSIONAL TO SUGGEST THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN RESEARCHED BUT HAS NOT BEEN RECEIVED. IT HAD PREVIOUSLY BEEN REPORTED THE LEAD HAD BEEN EXPLANTED AND REPLACED DUE TO APPARENT FRACTURE. REVIEW OF MANUFACTURER'S DATABASE VERIFIED PATIENT DEATH AND ALSO THAT THE PATIENT DID NOT HAVE A SPRINT FIDELIS LEAD MODEL IMPLANTED AT THE TIME OF DEATH. EVALUATION SUMMARY (B)(4) PROXIMAL CONDUCTOR FRACTURED, DEFIB CONDUCTOR DISTORTED, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED), BLOOD/BODY FLUID OUTER TUBING OVERLAY, OUTER TUBING KINKED/BUCKLED, OUTER TUBING OVERLAY MELTED AND COSMETIC ESC AND BREACHED CUT, OUTER INSULATION COSMETIC DEPRESSION, BLOOD IN/ON HELIX/LOBE MECHANISM. FULL LEAD IN SEGMENTS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT PATIENT "SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD" AND "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 SPRINT FIDELIS LEAD." FURTHER ALLEGES THAT AS DIRECT RESULT OF THE LEAD, PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES" AND "SUFFERED PHYSICAL INJURIES AND VARIOUS PHYSICAL MANIFESTATIONS OF EMOTIONAL DISTRESS ASSOCIATED WITH ONE OR MORE OF THE FOLLOWING: THE IMPLANTATION, RECALL, FAILURE, REMOVAL/REPLACEMENT, AND/OR INABILITY TO HAVE THE DEFECTIVE SPRINT FIDELIS LEAD REMOVED OR REPLACED." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN RESEARCHED AND NOT RECEIVED.

    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 85 YR Death| H| L 5076 IMPLANTABLE PACING LEAD| 7288 IMPLANTABLE PACEMAKER/CARDIO/DEFIB