BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3905658 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11536
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DISLODGED. IT WAS REPORTED THAT THE PATIENT HAD PRESENTED TO THE HOSPITAL DUE TO FATIGUE. THE PATIENT'S SYSTEM WAS EVALUATED AND HIGH PACING THRESHOLDS WERE REPORTED ALONG WITH LOSS OF CAPTURE. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS EXTRACTED AND A NEW LEAD WAS SUCCESSFULLY PLACED. NO FURTHER COMPLICATIONS WERE REPORTED. THIS PRODUCT HAS BEEN REMOVED FROM SERVICE AND IS NOT EXPECTED TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384543 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R P052| 0692| 4543