BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3211344 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08703
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 15, 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

    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 INITIAL INFORMATION THAT THERE WAS LEFT VENTRICULAR (LV) LOSS OF CAPTURE ON THIS LEAD. AT THIS FOLLOW-UP VISIT, NO INTERVENTION WAS TAKEN, AND THE PHYSICIAN ELECTED FOR FURTHER PERFORMANCE EVALUATION BEFORE PROCEEDING WITH ANY DEFINED ACTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SEVEN DAYS LATER, LV DISLODGEMENT WAS CONFIRMED INTO THE SUBCLAVIAN VEIN, AS SOURCE OF LOSS OF CAPTURE PREVIOUSLY OBSERVED. THIS LEAD WAS ABANDONED IN SITU AND A NEW LV LEAD WAS SUBSEQUENTLY IMPLANTED DUE TO THIN VEIN CONDITION OF THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310115 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R N119| 4543| 0185| 4136