BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4131450 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14784
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    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

    (B)(4). 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 PATIENT¿S PACEMAKER AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED MULTIPLE HIGH PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 2,000 OHMS. SOME UNDERSENSING AND HIGH THRESHOLDS WERE ALSO OBSERVED ON THE RV LEAD. ADDITIONAL INFORMATION FROM THE FIELD INDICATED THAT THE PATIENT IS PACEMAKER DEPENDENT. DURING A DEVICE UPGRADE PROCEDURE, SURGICAL INTERVENTION WAS PERFORMED AND THE PACEMAKER WAS EXPLANTED. NO DAMAGE OR ABNORMALITIES WERE NOTED WITH THE RV LEAD SO THE PHYSICIAN ELECTED TO TAKE IT OUT OF SERVICE AND INSERT IT INTO THE RIGHT ATRIAL PORT OF THE NEW DEVICE AS THE PATIENT DOES NOT HAVE AN ATRIAL LEAD AND THIS CREATED LESS BULK IN THE POCKET. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED IN ITS PLACE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611311 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R V183| 4457| 4088| S601| MISMATCH