BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1667269 · Received April 27, 2010

    Report

    Report Number
    2649622-2010-01888
    Event Type
    Death
    Date Received
    April 27, 2010
    Date of Event
    February 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0067-0070-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES PATIENT "SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD" AND "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES." LATER REPORTED BY PATIENT'S WIFE THAT PATIENT HAD BEEN HOSPITALIZED FOR CONGESTIVE HEART FAILURE, DEVICE WENT OFF 8 TIMES, AND WAS TOLD IT WAS A LEAD FRACTURE. PATIENT "TRANSPORTED TO ANOTHER HOSPITAL TO HAVE THE LEAD AND DEVICE REPLACE(D)." SHE REPORTED PATIENT DIED WITH CAUSE OF DEATH NOTED TO BE CANCER. REVIEW OF MANUFACTURER'S DATABASE VERIFIED PATIENT DEATH AND ALSO THAT THE PATIENT DID NOT HAVE THIS SPRINT FIDELIS LEAD IMPLANTED WHEN DIED. THERE IS NO ALLEGATION FROM THE HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    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 75 YR Death COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB