BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3041201 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02909
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 WITH THIS LEFT VENTRICULAR (LV) LEAD EXPERIENCED MUSCLE STIMULATION. THERE WAS ALSO LOSS OF CAPTURE AT 5 VOLTS 1.0 MILLISECONDS. THE LEAD WAS FOUND TO HAVE DISLODGED. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS SURGICALLY ABANDONED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142550 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4548

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 1297| 4548| 1254| H170| H120| 0158| MISMATCH