BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 3905706 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11562
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 13, 2014
    Report Date
    August 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS LEAD HAS BEEN RETURNED. BOSTON SCIENTIFIC HAS CONCLUDED IT IS UNLIKELY THAT DEVICE CHARACTERISTICS CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. 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

    (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 THE EVENING OF THE IMPLANT PROCEDURE. AN ATTEMPT TO ELECTRONICALLY REPOSITION THE LEAD WAS UNSUCCESSFUL. THE FOLLOWING DAY, A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384973 EASYTRAK 3 IMPLANTABLE LEAD LWP CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| L| R N140| 0296| 4592| 4549| 5076