BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT FIDELIS

    MDR report key: 2021184 · Received March 16, 2011

    Report

    Report Number
    2649622-2011-04048
    Event Type
    Death
    Date Received
    March 16, 2011
    Date of Event
    April 17, 2008
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    AN ALLEGATION FROM AN ATTORNEY INDICATED THE PATIENT "SUFFERED PHYSICAL INJURY, INCLUDING, BUT NOT LIMITED TO DEATH, EMERGENCY AND ADDITIONAL SURGERIES TO REMOVE OR REPLACE THE DEFECTIVE LEADS, UNNECESSARY SHOCKING, ADDITIONAL MEDICAL MONITORING, AND VARIOUS PHYSICAL MANIFESTATIONS OF EXTREME EMOTIONAL DISTRESS". THE ATTORNEY ALSO INDICATED THAT THE PATIENT DECEASED. APPROXIMATELY TWO YEARS AFTER THE FIRST ATTORNEY ALLEGATION, AN ALLEGATION FROM ANOTHER ATTORNEY INDICATED THE PATIENT IMPLANTED WITH A RIGHT VENTRICULAR LEAD IS DECEASED AND NO FURTHER INFORMATION WAS PROVIDED.

    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 48 YR Death| H| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB