BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3212564 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08787
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 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

    THIS LEAD REMAINS IN SERVICE AND HAS NOT BEEN RETURNED; THEREFORE A TECHNICAL ANALYSIS CANNOT BE CONDUCTED. WITHOUT A RETURNED LEAD IT IS NOT POSSIBLE TO DEFINITELY CONFIRM HOW THE LEAD MAY HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. 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 DURING A ROUTINE FOLLOW UP, THIS LEFT VENTRICULAR (LV) LEAD REVEALED HIGH PACING IMPEDANCES GREATER THAN 2,500 OHMS AND HIGH PACING THRESHOLDS. THE PHYSICIAN SUSPECTED A LEAD FRACTURE AS THE LEAD WAS UNABLE TO BE PACED. A REVISION PROCEDURE WAS PERFORMED AND REVEALED THAT THE LV LEAD APPEARED TO BE PINCHED. THE PHYSICIAN ELECTED TO REMOVED THE EXISTING DEVICE WHILE THE LEAD REMAINS IMPLANTED. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312448 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R