BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1951479 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23012
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 26, 2010
    Report Date
    July 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE RA LEAD WAS SURGICALLY ABANDONED. THERE WAS ALSO A REPORT OF NOISE ON THE LEAD AND UNABLE TO CAPTURE AT MAX OUTPUTS. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THE PHYSICIAN PLANNED TO MONITOR THE PATIENT VIA LATITUDE, WHICH IS A REMOTE MONITORING SYSTEM AND FOLLOW UP IN CLINIC AS USUAL. THE PHYSICIAN PLANNED TO BRING THE PATIENT INTO THE OFFICE AT AN EARLIER DATE IF THE OUT OF RANGE MEASUREMENTS CONTINUE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A LATITUDE YELLOW ALERT THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT ATRIAL (RA) LEAD WERE EXHIBITING HIGH OUT OFF RANGE PACING IMPEDANCE MEASUREMENTS. OVER THE LAST 18 MONTHS THERE HAD BEEN SPIKES IN THE RA IMPEDANCE MEASUREMENTS, BUT THIS WAS THE FIRST TIME THE RA LEAD MEASUREMENTS HAD GONE OVER 2,000 OHMS. THERE WAS NO EVIDENCE OF NOISE NOTED ON THE RA LEAD. FURTHER TROUBLESHOOTING TECHNIQUES WERE DISCUSSED BY A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    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 62 YR Hospitalization| L| R 4470| E110| T135| 0158