BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3910479 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-09979
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THE LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. THE HEALTH CARE PROFESSIONAL (HCP) WAS CALLING TO ASK FOR LEAD SPECIFICATIONS. THE HCP STATED THAT THE SURGEON WAS DOING TESTING ON THE LEAD. ADDITIONAL INFORMATION INDICATES THAT THE LEAD WAS REPLACED AND NO INFORMATION RECEIVED IF THE LEAD WILL BE RETURNED. LV LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387907 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R E030| 0158| 4087| H227| 4542| T135