BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 1660652 · Received April 16, 2010

    Report

    Report Number
    2649622-2010-01878
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    June 11, 2005
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. 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. THE CAUSE OF DEATH HAS BEEN RESEARCHED BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    ATTORNEY ALLEGES PATIENT "IMPLANTED WITH MEDTRONIC'S SPRINT FIDELIS LEADS, WAS INJURED AND DIED AS A RESULT. AS A DIRECT AND PROXIMATE RESULT OF MEDTRONIC'S DESIGN, MANUFACTURE, ASSEMBLY, MARKETING AND SALES OF THE SPRINT FIDELIS LEADS, (PATIENT HAS)SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, AND ECONOMIC LOSSES AND CONSEQUENTIAL DAMAGES." FURTHER ALLEGES THAT AS A RESULT OF "THE IMPLANTATION OF MEDTRONIC'S SPRINT FIDELIS LEADS, (PATIENT) SUFFERED FATAL INJURIES." THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. REVIEW OF MANUFACTURER'S DATABASE VERIFIED PATIENT'S DEATH AND ALSO THAT THE PATIENT DID NOT HAVE A SPRINT FIDELIS LEAD MODEL IMPLANTED. THE CAUSE OF DEATH HAS BEEN RESEARCHED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death 5076 IMPLANTABLE PACING LEAD| 7271 IMPLANTABLE PACEMAKER/CARDIO/DEFIB