BEUDAMED
    FDA Adverse Event Death Summary report: N

    FINELINE II

    MDR report key: 2060107 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06722
    Event Type
    Death
    Date Received
    April 15, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A PATIENT ADVOCATE THAT THE PATIENT WITH THIS IMPLANTED LEAD PASSED AWAY DUE TO HEART FAILURE. THE ADVOCATE ALLEGED THAT THE DEVICE DIDN'T WORK AND THAT THE LEADS CAME APART, AND THAT THE DEVICE DELIVERED THERAPY ONLY ONE TIME. THE ADVOCATE DID NOT KNOW THE DISPOSITION OF THE DEVICE OR LEADS, AND PROVIDED NO OTHER DETAILS REGARDING THE DEVICE, LEADS OR CAUSE OF DEATH. THE PATIENT'S BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THE LAST INFORMATION THE HEALTH CARE PROVIDER (HCP) HAD FOR THIS PATIENT WERE THE RESULTS OF A REMOTE MONITORING INTERROGATION; THAT INTERROGATION SHOWED EVERYTHING WAS NORMAL. THE REPRESENTATIVE WAS NOT ASKED TO INTERROGATE THE DEVICE OR PROGRAM IT OFF FOLLOWING THE PATIENT'S DEATH, AND HAD NO OTHER INFORMATION REGARDING THE DEVICE OR ALLEGATION. LEAD MEASUREMENTS WERE AVAILABLE UP TO THREE WEEKS PRIOR TO THE DATE OF THE PATIENT'S DEATH; REVIEW OF THOSE MEASUREMENTS SHOWED NO ANOMALIES. BECAUSE DEVICE DATA FOR THE THREE WEEKS PRIOR TO THE DATE OF DEATH WAS NOT AVAILABLE, WE ARE UNABLE TO DETERMINE WHETHER THE LEAD MEASUREMENTS REMAINED NORMAL AND STABLE, AND CANNOT CONFIRM OR REFUTE THE ALLEGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death 0184| E110| 4470