BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 1954069 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24276
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 LEAD WAS SURGICALLY ABANDONED DUE TO HIGH IMPEDANCE MEASUREMENTS WHICH WERE GREATER THAN 2,000 OHMS AND HIGH THRESHOLDS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4512

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention 4470| N119| 4512| H135| 0158| H175| 4592