BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT FIDELIS

    MDR report key: 1492395 · Received October 6, 2009

    Report

    Report Number
    2649622-2009-02341
    Event Type
    Injury
    Date Received
    October 6, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S029
    Removal / Correction Number
    Z-0070-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    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.

    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.

    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. EVALUATION SUMMARY (B)(4) DETAILED ANALYSIS OF THE DEVICE WAS NOT PERFORMED AT THIS TIME DUE TO PENDING LITIGATION. THEREFORE, WE ARE UNABLE TO FULLY EVALUATE THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT HAD REPORTED THAT THE DEVICE SHOCKS FOR NO REASON AND HE WANTED TO HAVE SYSTEM REMOVED AS "HEART IS FINE." ATTORNEY LATER ALLEGED THAT AS A RESULT OF THE "DEFECTIVE SPRINT FIDELIS" LEAD, THE PATIENT SUFFERED INJURIES "INCLUDING, BUT NOT LIMITED TO, DEATH, BEING SHOCKED BY THE DEFIBRILLATOR MULTIPLE TIMES WITHOUT CAUSE, WHICH RESULTED IN A LOSS OF ENJOYMENT OF LIFE, DUE TO THE KNOWLEDGE" THAT HE "COULD AT ANY TIME BE SUBJECTED TO FURTHER INJURIES ASSOCIATED WITH THE DEFECTIVE LEADS, AS WELL AS THE KNOWLEDGE" THAT HE "MIGHT BE ADVISED TO UNDERGO ADDITIONAL SURGERY TO CORRECT, REMOVE AND/OR REPLACE THE DEFECTIVE LEAD IN THE FUTURE." MANUFACTURER UNABLE TO CONFIRM THAT 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

    PATIENT REPORTED DEVICE SHOCKS FOR NO REASON AND HE WANTED TO HAVE SYSTEM REMOVED AS "HEART IS FINE." ATTORNEY LATER ALLEGED THAT AS A RESULT OF THE "DEFECTIVE SPRINT FIDELIS" LEAD, THE PATIENT SUFFERED INJURIES "INCLUDING, BUT NOT LIMITED TO, DEATH, BEING SHOCKED BY THE DEFIBRILLATOR MULTIPLE TIMES WITHOUT CAUSE, WHICH RESULTED IN A LOSS OF ENJOYMENT OF LIFE, DUE TO THE KNOWLEGE" THAT HE COULD AT ANY TIME BE SUBJECTED TO FURTHER INJURIES ASSOCIATED WITH THE DEFECTIVE LEADS, AS WELL AS THE KNOWLEDGE THAT HE MIGHT BE ADVISED TO UNDERGO ADDITIONAL SURGERY TO CORRECT, REMOVE AND/OR REPLACE THE DEFECTIVE LEAD IN THE FUTURE. MANUFACTURER UNABLE TO CONFIRM THAT THE PATIENT HAD DIED. IT WAS LATER DETERMINED THE PATIENT HAD NOT DIED, BUT RATHER, HAD THE LEAD REPLACED DUE TO OVERSENSING.

    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 53 YR Death| H| R 6935 IMPLANTABLE TACHY LEAD| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB