BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3061778 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06247
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    October 1, 2012
    Report Date
    March 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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 (LV) LEAD HAS A HISTORY OF HIGH IMPEDANCES, GREATER THAN 2,000 OHMS SINCE (B)(6) 2012. THE PATIENT WAS IN FOR A DEVICE FOLLOW-UP APPOINTMENT AND NO SYMPTOMS WERE REPORTED. ONE MONTH LATER, THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. IT WAS ALSO NOTED THAT THE LEAD WAS UNABLE TO CAPTURE. THE PHYSICIAN WAS CONCERNED WITH A LEAD INTERGRITY ISSUE NEAR THE POCKET. THERE WAS NOTHING CONFIRMED VIA CHEST X-RAY, HOWEVER UNUSUAL COILING NEAR THE POCKET WAS OBSERVED VIA FLUOROSCOPY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163463 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4542

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R 0186| 4542| MISMATCH| N119| H179