BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2910320 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00288
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    PHYSICIAN

    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 LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO A DISLODGEMENT. THE PHYSICIAN OPTED TO NOT RE-IMPLANT THE PATIENT WITH A NEW LV LEAD AS THEIR EJECTION FRACTION WAS GREATER THAN 35 PERCENT AND DEEMED NOT BE LV THERAPY DEPENDENT. SUBSEQUENTLY THE LV PORT WAS PLUGGED ON THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16951 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R 4470| N119| 4555| 4543| 0185