BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK

    MDR report key: 3213094 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09699
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS IN FOR A SYSTEM REVISION DUE TO AN INFECTED POCKET WHERE THE DEVICE WAS ERODING THROUGH THE SKIN. A COMPETITOR EPICARDIAL LEAD WAS PLACED AND ATTACHED TO A TEMPORARY VVI PACEMAKER PRIOR TO THE SYSTEM EXTRACTION. THE EPICARDIAL LEAD AND VVI PACEMAKER WERE GOING TO BE USED UNTIL THE INFECTION CLEARED. HOWEVER, DURING EXTRACTION OF THE ENDOCARDIAL RIGHT VENTRICULAR (RV) LEAD, THE PATIENT CODED AND DIED ON THE OPERATING TABLE. THE EXACT CAUSE OF DEATH WAS NOT KNOWN, BUT A MYOCARDIAL INFARCTION WAS SUSPECTED. THERE WERE NO SIGNS OF TAMPONADE OR EFFUSION. THE FIELD REPRESENTATIVE BELIEVES THE LEADS WERE BURIED WITH THE PATIENT AND THE HOSPITAL RETAINED THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312178 EASYTRAK IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4537

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R N161| N164| H170| 4086| 0157| 4537| N160| H210