BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2173293 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10588
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DIED A YEAR LATER FOR AN UNRELATED REASON. THERE WAS NO ALLEGATION OR EVIDENCE THE DISLODGEMENT CONTRIBUTED TO THE PATIENT'S DEATH. THE LEAD IS NOT EXPECTED TO BE RETURNED 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 THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED AND WAS FLOATING IN THE PATIENT'S ATRIUM. NO ADVERSE PATIENT EFFECTS WERE REPORTED AT THE TIME OF THE DISLODGEMENT. NO INTERVENTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 4076| 4542| P107| 0185