BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1474654 · Received September 17, 2009

    Report

    Report Number
    2649622-2009-02298
    Event Type
    Death
    Date Received
    September 17, 2009
    Date of Event
    November 25, 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
    TX, 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 TO SUGGEST THE DEATH WAS DEVICE RELATED. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM.THE CAUSE OF DEATH HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THE PATIENT DIED AS A "RESULT OF DEFECT" IN THE SPRINT FIDELIS LEAD. IT IS FURTHER ALLEGED THAT THE PATIENT HAD "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH." THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. IT WAS LATER ALLEGATED BY ATTORNEY THAT IN 2007, THE PATIENT "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."

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THE PATIENT DIED AS A "RESULT OF DEFECT" IN THE SPRINT FIDELIS LEAD. IT IS FURTHER ALLEGED THAT THE PATIENT HAD "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH." 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.

    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 64 YR Death 7278 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR| 5568 IMPLANTABLE PACING LEAD