BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3050071 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03594
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LEAD WAS NOT EXPECTED TO BE RETURNED. 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 WAS CONFIRMED TO BE DISLODGED DURING THE POST-OPERATIVE X-RAY. DURING THE REPOSITIONING PROCEDURE, THE PHYSICIAN ELECTED TO EXPLANT THIS LEAD AND A COMPETITIVE LV LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153395 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R