BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 3052741 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05008
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LV LEAD REMAINS IMPLANTED AND WILL NOT BE RETURNED. 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 INCREASED LEFT VENTRICULAR (LV) AND RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS WERE NOTED VIA REMOTE MONITORING NINE YEARS AFTER THE LEADS WERE INITIALLY IMPLANTED. INITIALLY A LEAD FRACTURE WAS SUSPECTED ON THE RV LEAD AS MEASUREMENTS OF GREATER THAN 2000 OHMS WERE OBSERVED AND A REVISION PROCEDURE WAS SCHEDULED. NO DOCUMENTED LOSS OF CAPTURE (LOC) WAS FOUND, HOWEVER IT WAS REPORTED THAT THE PATIENT MAY HAVE HAD A SYNCOPAL EPISODE, THE PATIENT IS PACEMAKER DEPENDANT. THE LV LEAD PACE IMPEDANCE MEASUREMENTS ALSO EXCEEDED 2000 OHMS A FEW DAYS LATER. UPON OPENING THE POCKET, THE LEADS WERE TESTED VIA THE PACING SYSTEM ANALYZER (PSA) AND ALL LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE LEADS WERE RECONNECTED TO THE DEVICE AND A LEAD EXTRACTION WAS SCHEDULED FOR THE NEXT DAY AT A NEW FACILITY. THE NEXT DAY A REVISION PROCEDURE WAS PERFORMED, HOWEVER A HEADER OR SETSCREW ISSUE WAS SUSPECTED UPON SEEING THE NORMAL LEAD MEASUREMENTS DURING IMPLANT TESTING AND WITH THE NEW DEVICE. AFTER THE REPLACEMENT OF THE FOUR YEAR OLD DEVICE IMPLANTED SUBCUTANEOUSLY, THE LEADS APPEARED TO BE WORKING NORMALLY. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155210 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4537

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 4537| 0157| H170| N119| 5076