BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1882259 · Received October 26, 2010

    Report

    Report Number
    2649622-2010-11961
    Event Type
    Death
    Date Received
    October 26, 2010
    Date of Event
    April 23, 2010
    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
    MO, 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. 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. REVIEW OF MANUFACTURER'S DATABASE VERIFIED PATIENT'S DEATH AND ALSO THAT THE SPRINT FIDELIS LEAD MODEL HAD BEEN CAPPED AS OF (B)(6)2008. 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.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES "ON (B)(6) 2004, DOCTORS...OPERATED ON OPERATED ON (PATIENT) AND INSTALLED A MEDTRONIC MAXIMO IMPLANTABLE CARDIAC DEFIBRILLATOR (MODEL # 7303) ALONG WITH THREE MEDTRONIC LEADS (MODEL # 419478ID, MODEL #507652, AND MODEL #6949). ON (B)(6) 2008, (PATIENT) WAS FIRST INJURED BY MEDTRONIC'S DEFECTIVE LEADS WHEN HE WAS SHOCKED SIX (6) TIMES IN THE MIDDLE OF THE NIGHT. EMERGENCY MEDICAL??STAFF TURNED OFF (PATIENT'S)ICD. THE MEDICAL STAFF DISCOVERED THAT THE INAPPROPRIATE SHOCKS WERE CAUSED BY A FRACTURE IN THE SPRINT FIDELIS LEAD (B)(4). ON (B)(6) 2018, (PATIENT) WAS FORCED UNDERGO A SURGICAL PROCEDURE TO REPLACE THE FRACTURED SPRINT FIDELIS." FURTHER ALLEGES AS A RESULT OF THE LEAD, PATIENT "HAS AN INCREASED RISK OF DEATH AND/OR MAJOR CARDIOVASCULAR EVENTS" AND "SUSTAINED SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES."

    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 84 YR Death| H| L| R 7303 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD