BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1951512 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23315
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 19, 2010
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED NOTED THAT A REVISION PROCEDURE TOOK PLACE AND THIS RV LEAD HAD ONCE AGAIN DISLODGED AND SHOWED NO CAPTURE AT MAXIMUM OUTPUTS. THE DEVICE WAS REPROGRAMMED AND THE RV LEAD REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT INCREASED THRESHOLDS WHICH LEAD TO A LOSS OF CAPTURE WERE NOTED ON THIS RIGHT VENTRICULAR (RV). IN ADDITION SENSING PROBLEMS WERE ALSO NOTED. A DISLODGMENT WAS SUSPECTED AND THIS RV LEAD WAS REPOSITIONED. AT A FOLLOW UP ONE DAY POST THE REPOSITIONING PROCEDURE THE PACING THRESHOLDS REMAINED HIGH AND A DECREASE IN R-WAVE SENSING WAS NOTED. THE OUTPUTS WERE REPROGRAMMED. A REVISION HAS BEEN PLANNED. 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 4457

    Patients

    Seq Age Sex Outcome Treatment
    1