BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1503995 · Received October 14, 2009

    Report

    Report Number
    2649622-2009-02862
    Event Type
    Death
    Date Received
    October 14, 2009
    Date of Event
    December 10, 2005
    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
    OK, 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.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES PATIENT RECEIVED INJURIES IN 2005 AND "INJURIES WERE SUSTAINED AS A RESULT OF A DEFECTIVE PRODUCT." REVIEW OF MANUFACTURER'S DATABASE REVEALED PATIENT DEATH. NO ALLEGATION FROM HEALTHCARE PROFESSIONAL THAT DEATH DEVICE RELATED. CAUSE OF DEATH RESEARCHED AND NOT RECEIVED. ATTORNEY LATER ALLEGES 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" AND AS A RESULT OF THE LEAD, PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH" AND PATIENT "HAS FURTHER SUFFERED PHYSICAL INJURIES AND VARIOUS PHYSICAL MANIFESTATIONS OF EMOTIONAL DISTRESS ASSOCIATED WITH ONE OR MORE OF THE FOLLOWING: THE IMPLANTATION, RECALL, FAILURE, REMOVAL/REPLACEMENT, AND/OR INABILITY TO THE DEFECTIVE SPRINT FIDELIS LEAD REMOVED OR REPLACED."

    Description of Event or Problem · 1

    ATTORNEY ALLEGES THE PATIENT RECEIVED INJURIES, AND THAT THESE "INJURIES WERE SUSTAINED AS A RESULT OF A DEFECTIVE PRODUCT." REVIEW OF MANUFACTURER'S DATABASE REVEALED PATIENT DEATH. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN RESEARCHED 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 7303 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR| 5076 IMPLANTABLE PACING LEAD