BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 1705858 · Received June 2, 2010

    Report

    Report Number
    2124215-2010-11890
    Event Type
    Death
    Date Received
    June 2, 2010
    Date of Event
    January 6, 2010
    Report Date
    May 19, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THAT THIS PATIENT'S PACEMAKER AND RV PACING LEAD WERE LIKELY BURIED WITH THE PATIENT AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC CRM FOR ANALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS EVENT WILL BE REOPENED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CARDIAC RHYTHM MANAGEMENT (CRM) RECEIVED INFORMATION THAT THIS PACEMAKER PATIENT PASSED AWAY TWO MONTHS POST-IMPLANT, AS A RESULT OF CONGESTIVE HEART FAILURE, PNEUMONIA AND INFECTION. THE PATIENT'S HEART RATE WAS REPORTED TO HAVE BEEN LOW APPROXIMATELY ONE MONTH POST-IMPLANT. IT WAS ALSO NOTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) PACING LEAD HAD DISLODGED; HOWEVER, THE DATE THIS OCCURRED WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death S601| 4457