BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2170892 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-11158
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    January 21, 2009
    Report Date
    June 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THIS PRODUCT WAS PART OF A SYSTEM THAT NEEDED SURGICAL INTERVENTION DUE TO A PATIENT INFECTION. THE PATIENT'S PACEMAKER WAS EXPLANTED AND THIS RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE. ALTHOUGH THIS PROCEDURE TOOK PLACE IN 2009, A BOSTON SCIENTIFIC EMPLOYEE FIRST RECEIVED NOTIFICATION OF THE EVENT VIA WARRANTY INFORMATION IN (B)(6) 2011.

    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 83 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)