BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1523173 · Received November 9, 2009

    Report

    Report Number
    2649622-2009-02918
    Event Type
    Death
    Date Received
    November 9, 2009
    Date of Event
    March 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 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 ALLEGED THE PATIENT "SUFFERED BODILY INJURY, AND RESULTING PAIN AND SUFFERING, DISABILITY, DISFIGUREMENT, MENTAL ANGUISH, LOSS OF CAPACITY OF ENJOYMENT OF LIFE, SHORTENED LIFE EXPECTANCY." REVIEW OF MANUFACTURER'S DATABASE VERIFIED PATIENT'S DEATH. NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. CAUSE OF DEATH RESEARCHED AND NOT RECEIVED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THE PATIENT HAS SUFFERED PHYSICAL INJURY, INCLUDING BUT NOT LIMITED TO REPEATED AND UNNECESSARY HIGH-VOLTAGE SHOCKS OF ELECTRICITY THROUGH THE CHEST, AS WELL AS AN UNACCEPTABLE INCREASE IN THE RISK OF FRACTURE, RESULTING IN FURTHER INJURY AND POSSIBLE DEATH. THE PATIENT "SUFFERED PHYSICAL AND OTHER INJURIES AS A RESULT OF THE RECALLED LEAD". AS A RESULT OF THE DEFECTIVE SPRINT FIDELIS LEAD WIRE SYSTEM, THE PATIENT HAS SUFFERED PHYSICAL AND EMOTIONAL INJURIES, INCLUDING BUT NOT NECESSARILY LIMITED TO DEATH, EMERGENCY AND ADDITIONAL SURGERIES TO REMOVE OR REPLACE THE DEFECTIVE LEADS, UNNECESSARY SHOCKING, ADDITIONAL MEDICAL MONITORING, AND VARIOUS PHYSICAL MANIFESTATIONS OR EXTREME EMOTIONAL DISTRESS. IT IS FURTHER ALLEGED THAT THE PATIENT HAD "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH."

    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 61 YR Death 4194 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR| 5076 IMPLANTABLE PACING LEAD