BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3971329 · Received July 31, 2014

    Report

    Report Number
    2124215-2014-10652
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    March 14, 2014
    Report Date
    April 16, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 EXHIBITED HIGH OUT-OF-RANGE PACING LEAD IMPEDANCE, LOSS OF CAPTURE (LOC) INTERMITTENT SENSING AFTER THE PATIENT FELL DUE TO BICYCLE ACCIDENT. THE LEAD HAD GREATER THAN 2000 OHMS IMPEDANCE WHEN TESTED WITH PACING SYSTEM ANALYZER (PSA) AND APPEARED TO BE FRACTURED. THE LEAD WAS CAPPED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446374 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 4470| 4543| 0185| N119