BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3211689 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-09457
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 14, 2013
    Report Date
    December 9, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SUBSEQUENTLY REMOVED FROM SERVICE NINETEEN MONTHS FOLLOWING THE INITIAL REPORTED OBSERVATIONS. EFFORTS TO OBTAIN ADDITIONAL PRODUCT ISSUE DETAILS WERE UNSUCCESSFUL. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS AND NOISE THE PHYSICIAN PLANNED TO DO ISOMETRICS TO TEST LEAD INTEGRITY. THE PATIENT HAD NO SYMPTOMS AND DOES NOT RELY ON ATRIAL PACING FOR SUPPORT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311676 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R 1762| 4470| 1860| T167| 5076