BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173611 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11518
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 18, 2011
    Report Date
    June 17, 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

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD HAD DISLODGED. DURING A ROUTINE PULSE GENERATOR CHANGE OUT PROCEDURE, THE LEAD WAS CUT AND CAPPED AND A NEW RA LEAD WAS ADDED. THE LOCAL FIELD REPRESENTATIVE REPORTED THAT THE PHYSICIAN WAS PREVIOUSLY AWARE OF THE DISLODGEMENT AND THAT THE DEVICE HAD BEEN PROGRAMMED TO VVI 40. THE PHYSICIAN WANTED TO WAIT TO REPLACE THE LEAD UNTIL A PULSE GENERATOR CHANGE OUT WAS NEEDED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    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 72 YR Required Intervention 0147| 4555| N119| 1861| 4469| 4592| 4470| T167