BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3092575 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-05946
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 25, 2013
    Report Date
    July 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD WAS PERFORMED. THE LEAD WAS RETURNED WITH THE GUIDEWIRE STUCK IN ITS LUMEN. INSPECTION OF THE LEAD BODY AND ELECTRODE TIP FOUND THE CONDUCTOR COILS TO BE STRETCHED AND DAMAGE TO THE INSULATION AT THE PROXIMAL END OF THE ANODE ELECTRODE. LABORATORY TESTING DID NOT IDENTIFY ANY LEAD CHARACTERISTICS THAT WOULD HAVE RESULTED IN THE CLINICAL OBSERVATION OF DISLODGEMENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO DISLODGEMENT. THE PHYSICIAN ALSO ATTEMPTED TO IMPLANT ANOTHER LEAD; HOWEVER, IT WAS DIFFICULT TO ACCESS THE CORONARY SINUS DUE TO PATIENT ANATOMY. THIS LEAD WAS NOT REPLACED WITH A NEW ONE. THIS LEAD IS NOW OUT OF SERVICE AND WAS RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193925 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R 0184| 4479| N119| 4543