BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1816757 · Received August 26, 2010

    Report

    Report Number
    2649622-2010-08918
    Event Type
    Death
    Date Received
    August 26, 2010
    Date of Event
    July 23, 2007
    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
    AR, 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. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM. THE CAUSE OF DEATH HAS BEEN RESEARCHED BUT HAS NOT BEEN RECEIVED. FURTHER ALLEGES PATIENT "DIED ON (B)(6) 2007, AND SAID DEATH WAS PROXIMATELY CAUSED BY THE MEDTRONIC LEADS." THERE IS NO ALLEGATION FROM HEALTH CARE PROFESSIONAL THAT DEATH WAS DEVICE RELATED. CAUSE OF DEATH HAS BEEN RESEARCHED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES PATIENT "HAS EXPERIENCED AND/OR IS AT RISK OF EXPERIENCING SERIOUS AND DANGEROUS SIDE EFFECTS INCLUDING BUT NOT LIMITED TO PAINFUL ELECTRIC SHOCKS TO THE HEART, PHANTOM FEARS/PAIN/SHOCKS TO THE HEART AND/OR FAILURE TO DELIVER NECESSARY SHOCK(S) TO THE HEART, CARDIAC ARREST, DEATH, AND/OR SUCH OTHER SIDE EFFECTS AS SHORTNESS OF BREATH, SHAKINESS, HEADACHES, DIZZINESS, PALE SKIN COLOR, SWEATING, NEED FOR SUBSEQUENT SURGERY TO REMOVE AND/OR REPLACE THE DEFECTIVE DEVICE, AS WELL AS OTHER SEVERE AND PERSONAL INJURIES WHICH ARE PERMANENT AND LASTING IN NATURE, PHYSICAL PAIN AND MENTAL ANGUISH, INCLUDING DIMINISHED ENJOYMENT OF LIFE, AS WELL AS THE NEED FOR LIFELONG MEDICAL TREATMENT, MONITORING AND/OR MEDICATIONS, AND FEAR OF DEVELOPING ANY OF THE ABOVE NAMED CONSEQUENCES."

    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 79 YR Death 4193 IMPLANTABLE PACING LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD