BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3070384 · Received April 22, 2013

    Report

    Report Number
    2124215-2013-06496
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    August 1, 2012
    Report Date
    March 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 APPROXIMATELY FOUR MONTHS AFTER THE PATIENT'S LAST GENERATOR CHANGE-OUT, THE LEFT VENTRICULAR (LV) PACING IMPEDANCE WAS GREATER THAN 2000 OHMS. ALL PACING VECTORS WERE TESTED, THE LEAD WAS NON-FUNCTIONAL, AND THE PHYSICIAN SUSPECTED THE LEAD WAS FRACTURED. RECENTLY, IT WAS DECIDED TO REPLACE THE LEAD AND THE PATIENT UNDERWENT SURGICAL INTERVENTION. THE LEAD WAS EVALUATED WITH THE GENERATOR AND PACING SYSTEM ANALYZER (PSA) AND FOUND TO HAVE NO CAPTURE IN THE BIPOLAR, TIP TO CAN, AND TIP TO RV PACING CONFIGURATIONS. FLUOROSCOPY EVALUATION WAS PERFORMED AND THE PHYSICIAN WAS UNABLE TO IDENTIFY A FRACTURE. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED, AND THE GENERATOR REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172899 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 5076| H217| N119| 4543| 6947| 1853