BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2780417 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12457
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 12, 2012
    Report Date
    September 17, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS LATER SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. 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

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RECEIVED INFORMATION THAT DURING A ROUTINE CHECK A POSSIBLE RIGHT VENTRICULAR (RV) LEAD FRACTURE WAS SUSPECTED. PACING IMPEDANCES HAD BEEN GREATER THAN 2500 OHMS IN UNIPOLAR AND BIPOLAR CONFIGURATIONS AND IN THE DAILY MEASUREMENTS FOR OVER TWO MONTHS. THIS WAS A CHANGE FROM PREVIOUS MEASUREMENTS OF 400 OHMS RANGE. IN ADDITION, THERE WAS NO CAPTURE AT MAXIMUM OUTPUT AND NO SENSING WITH SEVERAL NOISE EPISODES ALSO NOTED. THIS PATIENT WAS NOT DEVICE DEPENDENT BUT DID COMPLAIN OF SHORTNESS OF BREATH. A PRIOR DEVICE CHECK NOTED LESS THAN 50% PACING IN THE VENTRICLE AND AROUND 60% AT THIS RECENT CHECK AND THOUGHT RELATED TO THE LOSS OF SENSING. HOWEVER, THE PHYSICIAN DID NOT THINK THIS WAS RELATED. THE PATIENT HAD REPORTED A PHYSICAL ALTERCATION INVOLVING THEIR CHEST AT SOME POINT AND WAS BEING ADMITTED AS AN X-RAY WAS TO BE PERFORMED. NO FURTHER 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 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 4471| S606| 4470