BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1863635 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15674
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    July 31, 2010
    Report Date
    July 31, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT REMAINS IN SERVICE, IT WILL NOT BE RETURNED FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION RELATED TO THIS EVENT AVAILABLE TO THE COMPANY AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, THE PATIENT EXPERIENCED MUSCLE STIMULATION IN HIS ABDOMEN. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED LOSS OF CAPTURE AND THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASED THRESHOLD MEASUREMENTS. THE CHEST X-RAY REVEALED THAT THE RA LEAD HAD DISLODGED, HOWEVER THE RV LEAD APPEARED TO REMAIN IN GOOD POSITION. THERE WAS CONCERN OVER A HIGH CURRENT OF INJURY OR A POSSIBLE LEAD PERFORATION. THE RA LEAD WAS EXPLANTED AND A NEW ACTIVE FIXATION LEAD WAS SUCCESSFULLY IMPLANTED. THE RV LEAD WAS REPOSITIONED AND YIELDED GOOD MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R