BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2910785 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16409
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 19, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THIS LEAD WILL BE AVAILABLE FOR RETURN. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE OR IF THE LEAD IS RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD HAD BECOME DISLODGED ONE DAY POST IMPLANT. A LEAD REVISION WAS PERFORMED TO EXPLANT THIS LEAD AND A NON BOSTON SCIENTIFIC LEAD WAS IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS. A REQUEST FOR THE LEAD TO BE RETURNED HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17088 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R N141| 4549| 4136| MISMATCH