BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 1853964 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-17266
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 6, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED SEVERED 7.5 CENTIMETERS FROM THE PIN. ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED. THE LEAD WAS ALSO TESTED BY INSERTING AND REMOVING THE TERMINAL PIN FROM AN IS-1 HEADER WITH SUCCESS AND WITHOUT ANY IRREGULARITIES OBSERVED. THE RETURNED PORTION OF THE LEAD WAS DETERMINED TO HAVE BEEN ELECTRICALLY CONTINUOUS. THE CLINICAL OBSERVATION WAS NOT ABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE LEAD HAS BEEN RETURNED FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE IN REGARDS TO THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION FROM A COMPETITIVE FIELD REPRESENTATIVE (FR) THAT THE PATIENT WITH THIS LEAD UNDERWENT A LEFT VENTRICULAR (LV) LEAD REVISION PROCEDURE DURING THE PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTIES GETTING THE LV AND RIGHT ATRIAL (RA) SETSCREWS LOOSE. A TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED SOME TROUBLE SHOOTING IDEAS WITH THE FR. THE OUTCOME OF THE CASE IS UNKNOWN AT THIS TIME. AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 77 YR Required Intervention 4543| 4470| 0158| H210