BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2172972 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11714
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 10, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NEW INFORMATION WAS RECEIVED THAT A FEW DAYS AFTER THE PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX. MEDICAL INTERVENTION WAS REQUIRED TO INSERT A TUBE ALLOWING THE AIR TO ESCAPE. THE ISSUE WAS RESOLVED AND THE PATIENT HAD NO FURTHER ADVERSE EFFECTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENTS LEADS WERE ATTEMPTED. THE LEADSBECAME DISLODGED BEFORE THE POCKET WAS CLOSED AND THE PHYSICIAN WAS UNABLE TO REPOSITION THEM. THE PHYSICIAN DECIDED TO STOP THE CASE AND TRY AGAIN AT A LATER DATE. THE DEVICE AND LEADS WERE EXPLANTED AND WERE NOT REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R