BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3043248 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01718
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 22, 2013
    Report Date
    November 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NEARLY A YEAR AFTER THIS INITIAL ALLEGATION, THE ATRIAL LEAD WAS SURGICALLY ABANDONED DUE TO THE ONGOING ISSUE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW UP VISIT, THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND WAS FOUND TO HAVE FRACTURED. IN ADDITION, REVIEW OF AN ELECTROGRAM (EGM) REVEALED THAT THE ATRIAL LEAD HAD OVERSENSED. THE PHYSICIAN ELECTED TO REPROGRAM THE DEVICE AS THE PATIENT HAS THEIR OWN SINUS RHYTHM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145275 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R