BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1952285 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24128
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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 RIGHT ATRIAL LEAD WAS EXPLANTED ONE DAY POST IMPLANT DUE TO DISLODGEMENT. IT WAS REPORTED THAT THE CAUSE OF THE LEAD DISLODGEMENT WAS THAT THE PATIENT ACTIVELY USED HER ARM AFTER IMPLANT AGAINST THE PHYSICIAN'S ORDERS. THIS LEAD WAS EXPLANTED AND DISCARDED IN THE HOSPITAL'S CONTAMINATION BIN. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED.

    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 57 YR Required Intervention 4470| 4469| E110| 0185| 0184