BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 2151024 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06014
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 5, 2011
    Report Date
    September 23, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DEVICE WAS REPROGRAMMED TO MAXIMUM OUTPUTS AND A LEAD REVISION HAS BEEN SCHEDULED. WHEN A RESOLUTION HAS BEEN REACHED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE LEAD IS NOT EXPECTED TO 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.

    Additional Manufacturer Narrative · 1

    THE LV LEAD OUTPUTS WERE INCREASED AND THE PATIENT WILL BE SEEN IN THREE MONTHS TO RE-EVALUATE THE LEAD AND SEE IF THE THRESHOLDS HAD STABILIZED. AT THIS TIME, THIS LV LEAD REMAINS IMPLANTED AND IN SERVICE. 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 THIS LEFT VENTRICULAR (LV) LEAD HAS PRESENTED WITH AN INCREASE IN PACING THRESHOLDS SINCE IT WAS IMPLANTED. THERE WAS INTERMITTENT LOSS OF CAPTURE NOTED BUT DID NOT RESULT IN VENTRICULAR ASYSTOLE AS THE ASSOCIATED RIGHT VENTRICULAR (RV) LEAD IS OPERATING NORMALLY AND PROVIDING EFFECTIVE PACING THERAPY. IT IS SUSPECTED THAT THE LV LEAD MAY HAVE DISLODGED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE LV LEAD WAS SUCCESSFULLY REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PACING THRESHOLD MEASUREMENTS ON THIS LV LEAD HAVE CONTINUED TO INCREASE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R