BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1474639 · Received September 17, 2009

    Report

    Report Number
    2649622-2009-02270
    Event Type
    Death
    Date Received
    September 17, 2009
    Date of Event
    September 4, 2007
    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
    NY, 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. IT IS NOT KNOWN IF THE DEVICE WAS EXPLANTED POST-MORTEM. THE CAUSE OF DEATH HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED. ATTORNEY LATER ALLEGES PATIENT "EXPERIENCED SERIOUS AND DANGEROUS SIDE EFFECTS INCLUDING BUT NOT LIMITED TO PAINFUL ELECTRIC SHOCKS TO THE HEART, PHANTOM FEARS/PAIN/SHOCKS TO THE HEART AND/OR FAILURE TO DELIVER NECESSARY SHOCK(S) TO THE HEART, CARDIAC ARREST, DEATH, AND/OR SUCH OTHER SIDE EFFECTS AS SHORTNESS OF BREATH, SHAKINESS, HEADACHES, DIZZINESS, PALE SKIN COLOR, SWEATING, NEED FOR SUBSEQUENT SURGERY TO REMOVE AND/OR REPLACE THE DEFECTIVE DEVICE, AND/OR OTHER SEVERE AND PERMANENT HEALTH CONSEQUENCES" AND "REQUIRED HEALTH CARE SERVICES AND DID INCUR MEDICAL, HEALTH INCIDENTAL AND RELATED EXPENSES."

    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. 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 THAT AS A RESULT OF THE 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/SHE COULD AT ANY TIME BE SUBJECTED TO FURTHER INJURIES ASSOCIATED WITH THE DEFECTIVE LEADS, AS WELL AS THE KNOWLEDGE THAT HE/SHE MIGHT BE ADVISED TO UNDERGO ADDITIONAL SURGERY TO CORRECT, REMOVE AND/OR REPLACE THE DEFECTIVE LEADS IN THE FUTURE." 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. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REVEALED THAT AT THE PATIENT'S LAST DEVICE CHECK IN 2007, THE DEVICE AND LEADS WERE "FUNCTIONING NORMALLY."

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT AS A RESULT OF THE 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/SHE COULD AT ANY TIME BE SUBJECTED TO FURTHER INJURIES ASSOCIATED WITH THE DEFECTIVE LEADS, AS WELL AS THE KNOWLEDGE THAT HE/SHE MIGHT BE ADVISED TO UNDERGO ADDITIONAL SURGERY TO CORRECT, REMOVE AND/OR REPLACE THE DEFECTIVE LEADS IN THE FUTURE." THERE IS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. FOLLOW UP WITH MANUFACTURER'S REPRESENTATIVE REVEALED THAT AT THE PATIENT'S LAST DEVICE CHECK IN EARLY 2007, THE DEVICE AND LEADS WERE "FUNCTIONING NORMALLY."

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THAT AS A RESULT OF THE 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/SHE COULD AT ANY TIME BE SUBJECTED TO FURTHER INJURIES ASSOCIATED WITH THE DEFECTIVE LEADS, AS WELL AS THE KNOWLEDGE THAT HE/SHE MIGHT BE ADVISED TO UNDERGO ADDITIONAL SURGERY TO CORRECT, REMOVE AND/OR REPLACE THE DEFECTIVE LEADS IN THE FUTURE." 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 51 YR Death| O 4076 IMPLANTABLE PACING LEAD| 7299 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR| 4194 IMPLANTABLE PACING LEAD