BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2161216 · Received July 13, 2011

    Report

    Report Number
    2124215-2011-07919
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS ATRIAL LEAD WAS SURGICALLY ABANDONED DUE TO AN UNSPECIFIED PRODUCT PERFORMANCE ISSUE. IT WAS LATER PROVIDED THAT THIS PATIENT HAD BEEN SEEN BY A DIFFERENT CARDIOLOGIST. THIS CARDIOLOGIST HAD THE RIGHT ATRIAL LEAD TURNED OFF FOR OVER YEAR AND REPORTED THAT THE LEAD WAS NOT WORKING. HOWEVER, THE PATIENT RETURNED TO THE IMPLANTING CARDIOLOGIST AND AT THE TIME OF A DEVICE CHANGEOUT THIS LEAD WAS TURNED BACK ON AND TESTED WITH NORMAL FUNCTION. HOWEVER, AS THE IMPLANTING PHYSICIAN DID NOT KNOW THE EXTENT AND LAST YEAR'S HISTORY OF THIS LEAD, IT WAS FELT THE BEST OPTION WAS TO REPLACE THIS LEAD AND AVOID A POTENTIAL FUTURE ADDITIONAL PROCEDURE FOR THIS PATIENT. 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 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)