BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2060054 · Received April 15, 2011

    Report

    Report Number
    2124215-2011-06043
    Event Type
    Injury
    Date Received
    April 15, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THIS DEVICE AND LEAD REMAIN IN SERVICE. 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 PACEMAKER AND RIGHT VENTRICULAR PACING LEAD EXHIBITED INCREASED THRESHOLD MEASUREMENTS. AUTOMATIC CAPTURE HAD BEEN PROGRAMMED ON AT A PREVIOUS DEVICE CHECK. UPON INTERROGATION, THE DEVICE WAS FOUND TO BE IN RETRY AT 3.5V AT .4 MS. A STORED EPISODE REVEALED LOSS OF CAPTURED WITH ASYSTOLE FOR 2.1 SECONDS. THE PATIENT HAS BEEN EXPERIENCING SHORTNESS OF BREATH AND FATIGUE. OUTPUTS WERE REPROGRAMMED TO 6.5 V AT 1.0 MS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening S601| 4470