BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 1524790 · Received November 10, 2009

    Report

    Report Number
    2649622-2009-02949
    Event Type
    Death
    Date Received
    November 10, 2009
    Date of Event
    June 9, 2009
    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
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. 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 LEAD IS PART OF THE ADVISORY FOR THIS MODEL. WE HAVE NO INFORMATION FROM A HCP (HEALTH CARE PROFESSIONAL) TO SUGGEST THE DEATH WAS LEAD RELATED. IT IS NOT KNOWN IF THE LEAD WAS EXPLANTED POST-MORTEM. THE CAUSE OF DEATH HAS BEEN RESEARCHED, BUT HAS NOT BEEN RECEIVED. ATTORNEY LATER ALLEGES PATIENT "SUFFERED REPEATED SHOCKS AND FRACTURES, AFTER THE ENHANCED MONITORING SYSTEM WAS IN PLACE, AND THE MONITORING FAILED. (PATIENT) SUFFERED THESE SHOCKS AND FRACTURES WITHOUT ANY ALARM SOUNDING FROM THIS PURPORTEDLY ENHANCED MONITOR." FURTHER ALLEGES PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES" AND "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 HAVE THE DEFECTIVE SPRINT FIDELIS LEAD REMOVED OR REPLACED."

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. 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 LEAD IS PART OF THE ADVISORY FOR THIS MODEL. WE HAVE NO INFORMATION FROM A HCP (HEALTHCARE PROFESSIONAL) TO SUGGEST THE DEATH WAS LEAD RELATED. IT IS NOT KNOWN IF THE LEAD WAS EXPLANTED POST-MORTEM. THE CAUSE OF DEATH HAS BEEN RESEARCHED BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    AN ATTORNEY ALLEGED THE PATIENT "SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD." IT WAS ALSO ALLEGED IN 2008, 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 [LEAD]." AS A RESULT, THE PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES." REVIEW OF THE MANUFACTURER'S DATABASE VERIFIED THE PATIENT'S DEATH. NO ALLEGATION WAS RECEIVED FROM A HCP THAT THE DEATH WAS LEAD RELATED. CAUSE OF DEATH WAS RESEARCHED BUT NOT RECEIVED.

    Description of Event or Problem · 1

    AN ATTORNEY ALLEGED THE PATIENT "SUFFERED PHYSICAL AND OTHER INJURY AS A RESULT OF THE RECALLED LEAD." IT WAS ALSO ALLEGED IN 2008, 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 [LEAD]." AS A RESULT, THE PATIENT "SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, MENTAL ANGUISH, ECONOMIC LOSSES AND OTHER DAMAGES." REVIEW OF THE MANUFACTURER'S DATABASE VERIFIED THE PATIENT'S DEATH. NO ALLEGATION WAS RECEIVED FROM A HCP THAT THE DEATH WAS LEAD RELATED. CAUSE OF DEATH WAS RESEARCHED, BUT 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 82 YR Death 5076 IMPLANTABLE PACING LEAD| 7297 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR| 4194 IMPLANTABLE PACING LEAD