BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2911330 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16252
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 27, 2011
    Report Date
    March 7, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE LOCAL FIELD REPRESENTATIVE THAT AN X-RAY WAS PERFORMED, HOWEVER, THE RESULTS ARE NOT KNOWN. THE PHYSICIAN PLANS TO MONITOR THE DEVICE SYSTEM. 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 LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND IS NOT EXPECTED TO BE RETURNED. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS, WHICH ACTIVATED THE LEAD SAFETY SWITCH (LSS) FEATURE. REVIEW OF DEVICE MEMORY REVEALED THAT THE LEAD EXHIBITED NOISE THAT HAD BEEN PREVIOUSLY OBSERVED APPROXIMATELY ONE YEAR AGO, WHILE THE OUT OF RANGE PACING IMPEDANCE MEASUREMENTS BEGAN APPROXIMATELY TWO WEEKS AGO. THE LSS FEATURE WAS RESET AND ALL LEAD MEASUREMENTS WERE OBSERVED TO BE STABLE AND ACCEPTABLE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT APPROXIMATELY SIX YEARS LATER, THE PACEMAKER AND RA LEAD EXHIBITED UNDERSENSING AND PACING INHIBITION. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS THAT RESULTED IN DEPLETION OF THE PACEMAKER BATTERY. AN INVASIVE PROCEDURE WAS PERFORMED. THE PACEMAKER WAS EXPLANTED AND REPLACED AND THE LEADS WERE SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18525 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4479

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4457| S603| 4479