BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2192650 · Received August 5, 2011

    Report

    Report Number
    2124215-2011-13339
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    November 26, 2008
    Report Date
    June 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED. 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 AT A ROUTINE FOLLOW-UP THIS LEFT VENTRICULAR PACING LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE (LOC). PRIOR TO THE FOLLOW-UP, THE PATIENT HAD UNDERGONE A CORONARY ARTERY BYPASS PROCEDURE FOR LEFT MAIN DISEASE. THERE WAS CONCERN THE LEAD HAD FRACTURED. THE LEAD WAS CAPPED AND SUCCESSFULLY REPLACED. 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 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| MISMATCH