BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1945915 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-22757
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    March 11, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    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 PATIENT CONTACTED PATIENT SUPPORT IN (B)(6) 2010 TO ASK ABOUT A RECENT DELIVERY OF A NEW LATITUDE COMMUNICATOR. PATIENT SUPPORT WAS INFORMED THAT THE PATIENT HAD UNDERGONE A SYSTEM REPLACEMENT PROCEDURE IN (B)(6) 2010 DUE TO INFECTION. THE PATIENT HAD BEEN PRESENTED TO THE ELECTROPHYSIOLOGY ((EP) LABORATORY BACK IN (B)(6) 2010. THE PATIENT'S CHRONIC RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE SURGICALLY CAPPED. A REPLACEMENT LV LEAD WAS IMPLANTED. THE PATIENT'S CHRONIC RA LEAD WAS NOT REPLACED DUE TO ATRIAL FIBRILLATION. THE CHRONIC DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. THE EVENT ANALYSIS DEPARTMENT RECEIVED INFORMATION FROM THE CLINIC NURSE THAT DURING THE PRE-DISCHARGE CHECK, THE POCKET DRESSING WAS SATURATED WITH BLOOD AND THERE WAS INTERMITTENT DIAPHRAGMATIC STIMULATION. IT APPEARS THAT THE ISSUE WAS RESOLVED AND THERE WAS NO INTERVENTION UNDERTAKEN FOR THE DIAPHRAGMATIC STIMULATION. THE PATIENT WAS CHECKED AGAIN (2-WEEKS POST-IMPLANT) AND THERE WAS STILL INTERMITTENT DIAPHRAGMATIC STIMULATION. NO INTERVENTION OR PROGRAMMING CHANGES WERE MADE AT THAT TIME. IN (B)(6) 2010, THE PATIENT WAS ADMITTED FOR POSSIBLE INFECTION AND A POCKET REVISION PROCEDURE WAS PERFORMED. BASED ON EXAMINATION OF THE POCKET SITE AND BLOOD CULTURE RESULTS, THE PHYSICIAN FELT THAT THE INFECTION WAS VERY SUPERFICIAL. THE DEVICE AND LEAD SYSTEM WAS LEFT IMPLANTED AND THE PATIENT WAS STARTED ON ANTIBIOTICS. IN (B)(6) 2010, THE PATIENT CONTINUED TO EXPERIENCE RECURRENT POCKET DRAINAGE AND SWELLING. THE PATIENT WAS THEN REFERRED TO ANOTHER FACILITY AND WAS SCHEDULED FOR DEVICE/LEAD SYSTEM EXTRACTION. IN (B)(6) 2010, THE PATIENT'S DEVICE AND LEAD SYSTEM WERE EXTRACTED AND REPLACED. AN RA LEAD WAS ATTEMPTED BUT WAS NOT IMPLANTED DUE TO NO RA ACTIVITY (RA STANDSTILL). THE REPLACEMENT DEVICE'S RA PORT WAS PLUGGED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R H170| MISMATCH| N119| 4543| ZY52| 1488T| 0158