BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2005468 · Received March 2, 2011

    Report

    Report Number
    2649622-2011-03133
    Event Type
    Death
    Date Received
    March 2, 2011
    Date of Event
    January 24, 2011
    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
    NY, US
    Reporter Occupation
    ATTORNEY

    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. REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT AS A RESULT OF THE LEAD, PATIENT SUFFERED INJURIES RELATING TO "DEFECTIVE SPRINT FIDELIS LEADS INCLUDING, BUT NOT LIMITED TO, BEING SHOCKED BY THE DEFIBRILLATOR MULTIPLE TIMES WITHOUT CAUSE. (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 OR REPLACE THE DEFECTIVE DEVICE, 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 HEALTH 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 76 YR Death (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB