BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 4150866 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17904
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    April 29, 2014
    Report Date
    September 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A RETURN REQUEST WAS SENT; HOWEVER, THE FIELD REPRESENTATIVE REPLIED THAT THE LEAD WILL NOT 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 DISLODGED DUE TO TWIDDLER¿S SYNDROME. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE LEAD DISLODGED AFTER HAVING BEEN STABLE FOR AT LEAST SIX MONTHS AND THE FIELD REPRESENTATIVE WAS ONLY MADE AWARE OF IT DURING THE EXPLANT PROCEDURE. THIS LV LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633216 EASYTRAK 3 IMPLANTABLE LEAD LWP CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R N160| 4135| 4549| 0292