BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 2052841 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-03814
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE DEVICE HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. 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 THE PATIENT IMPLANTED WITH THIS DEVICE SYSTEM EXPERIENCED DIAPHRAGMATIC STIMULATION IN ALL PROGRAMMED VECTORS WITH NO CAPTURE. THE PATIENT CAME IN FOR AN ABLATION PROCEDURE AND THE PATIENTS PHYSICIAN ELECTED TO PERFORM AND INVASIVE REVISION PROCEDURE. DURING THE PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS BROKE INTO MANY PIECES DURING THE LASER EXTRACTION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4538

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 4538| N119| 4542| 0125| 4269| 1821| H177| 1861| H170