BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 4140213 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16707
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 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). THE EXPLANTED LEAD WILL NOT 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 DURING THE DEVICE CHECK ONE DAY POST-IMPLANT, THIS RIGHT ATRIAL (RA) LEAD WAS SENSING, BUT EXHIBITED LOSS OF CAPTURE EVEN AT MAXIMUM PACING OUTPUTS. THE RA LEAD WAS PROGRAMMED OFF AND THE DEVICE WAS SET TO PACE ONLY IN THE RIGHT VENTRICLE (RV) AT 50 PPM. A LEAD REVISION WAS PLANNED, DEPENDING ON HOW THE PATIENT FELT WITHOUT RA PACING. HOWEVER, WHEN THE PATIENT WAS LEAVING THE HOSPITAL LATER THAT DAY, THEY FELT LIGHT-HEADED AND WERE HYPOTENSIVE. THE CAUSE WAS NOT DETERMINED, BUT IT WAS CONSIDERED THAT THE PACING RATE MIGHT HAVE BEEN TOO LOW AND THE DEVICE WAS REPROGRAMMED TO VVI 70. THE FOLLOWING DAY, THE PATIENT¿S BLOOD PRESSURE WAS STILL LOW, SO THE DEVICE WAS REPROGRAMMED TO VVI 55 TO REDUCE RV PACING AND THE RA LEAD REVISION WAS SCHEDULED. AN X-RAY CONFIRMED THE RA LEAD WAS DISLODGED AND THE PHYSICIAN BELIEVED THE DISLODGEMENT WAS DUE TO THE PATIENT¿S ANATOMY AND THE SIZE OF THE PATIENT¿S ATRIUM. THIS LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620593 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 4480| 4137| K287