BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3213669 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-07947
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED A CUT IN THE INSULATION HOWEVER THE LEAD TIP AND TINES WERE INTACT AND UNDAMAGED. HENCE, THE PRODUCT ANALYSIS COULD NOT CONFIRM LEAD DISLODGMENT AS THERE WERE NO DAMAGE OR DEFECTS WHICH WOULD LEAD TO DISLODGMENT. THE ALLEGATION OF HOLE IN THE INSULATION WAS CONFIRMED THROUGH VISUAL INSPECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR (LV) LEAD WAS DISLODGED. THE PHYSICIAN PLANNED REPOSITIONING IT HOWEVER, AS THEY WERE FLUSHING THE LEAD, A HOLE IN THE INSULATION WAS NOTED. THIS LEAD WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314233 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4542| N141| 4470| 7120| E110