BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2052148 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03193
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    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

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ONE WEEK POST OPERATIVE FOLLOW UP VISIT, THIS RIGHT VENTRICULAR LEAD DISPLAYED INCREASED THRESHOLD AND DECREASED AMPLITUDE MEASUREMENTS. LEAD DISLODGEMENT WAS SUSPECTED, HOWEVER, NOT CONFIRMED PER X-RAY. A REVISION PROCEDURE IS INTENDED IN THE NEAR FUTURE. THE PATIENT WITH THIS LEAD IS PACING DEPENDENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A REVISION PROCEDURE WAS PERFORMED. FLUOROSCOPY DID NOT CONFIRM THIS LEAD WAS DISLODGED, HOWEVER THE LEAD HAD STRETCHED AND THE SUTURES WERE LOOSE ON THE SUTURE SLEEVE. IT WAS STILL THOUGHT THIS LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED AND NORMAL MEASUREMENTS WERE OBTAINED.

    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 Other| R