BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2040112 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00682
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTEMPTED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A NEW IMPLANT PROCEDURE WAS PERFORMED AND THIS RIGHT VENTRICULAR LEAD WAS IMPLANTED AT THE APEX WITH NORMAL MEASUREMENTS. HOWEVER, THE SUTURE SLEEVE HAD TO BE CUT AND PUSHED DEEPLY TO SUTURE THE LEAD IN PLACE AS THE HEART WAS VERY LARGE. AFTER DEVICE CONNECTION, THE POCKET WAS CLOSED AND PACING FAILURE WAS NOTED ON THE ELECTROCARDIOGRAM. A CHEST X-RAY WAS PERFORMED AND REVEALED THAT THE LEAD HAD DISLODGED. THE POCKET WAS REOPENED AND THE LEAD WAS FIXED AGAIN. HOWEVER, THE LEAD MOVED AGAIN AFTER THE SUTURE SLEEVE WAS PLACED. THE LEAD WAS THEN REPLACED TO A (B)(4) AND DIFFICULTY WAS EXPERIENCED INSERTING THE NEW LEAD INTO THE RIGHT VENTRICLE. THE PROCEDURE WAS STOPPED DUE TO EXCESSIVE BLEEDING AND INCREASED X-RAY TIME. THE NEXT DAY, THE 4137 LEAD WAS IMPLANTED FROM THE RIGHT SIDE PROPERLY. NO ADDITIONAL 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 Other| R