BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 1862159 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-16083
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 27, 2010
    Report Date
    April 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED. SETSCREW MARKS WERE NOTED ON THE TERMINAL PIN AND TERMINAL RING ASSEMBLY. THE OUTER COIL WAS VISUALLY FRACTURED. RESISTANCE TESTING WAS THEN COMPLETED TO ASSESS THE LEAD'S ELECTRICAL INTEGRITY. MEASUREMENTS DID NOT PASS DUE TO THE FRACTURE ON THE OUTER COIL. THE OUTER COIL APPEARED SLIGHTLY FLATTENED AT APPROXIMATELY 46 CM FROM THE TERMINAL PIN WHERE ALL 3 COILS WERE FRACTURED. THE DAMAGE APPEARED TO BE CONSISTENT WITH LOCALIZED COMPRESSIVE STRESS BY ENTRAPMENT IN THE CLAVICLE/FIRST-RIB REGION. LABORATORY ANALYSIS CONFIRMED THE REPORTED FIELD ALLEGATION OF A LEAD FRACTURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE LEFT VENTRICULAR (LV) LEAD WAS UNABLE TO BE REMOVED. A NEW RA AND RV LEAD WERE IMPLANTED, HOWEVER, LV THRESHOLD MEASUREMENTS WERE NOTED TO BE INCREASED. PHYSICAL INSULATION BREACHES WERE OBSERVED ON THE LV LEAD. A REPAIR KIT WAS SUCCESSFULLY USED ON THE LV LEAD, WITH THE OUTPUT PROGRAMMED TO 4.5V AT 1.5MS. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. APPROXIMATELY ONE MONTH LATER, THE PATIENT WAS REFERRED FOR AN EPICARDIAL LV LEAD PLACEMENT. AT THAT TIME, THE ENDOCARDIAL LV LEAD WAS REMOVED. THE SURGEON NOTED THAT NO FORCE WAS REQUIRED TO REMOVE THE LEAD. THE FIELD REPRESENTATIVE WAS NOT SURE IF THE FRACTURE WAS LOCATED WITH THE TIP OR RING OF THE LEAD; HOWEVER, RECONFIRMED THE HIGH IMPEDANCES AND NOTED THERE WAS NO CAPTURE. THE LEAD HAS SINCE BEEN RETURNED AND IS CURRENTLY IN ANALYSIS. UPON COMPLETION FROM ANALYSIS, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR PACING LEAD WAS FRACTURED. IT WAS REPORTED THAT AN INCREASE IN PACING THRESHOLD MEASUREMENTS WAS OBSERVED, THEREFORE, A CHEST X-RAY WAS PERFORMED AND THE LEAD FRACTURED WAS VISUALIZED. THE LEAD WAS ELECTRICALLY DEACTIVATED AND THE PATIENT'S PHYSICIAN PLANNED TO RE-ASSESS THE PATIENT'S LEFT VENTRICULAR FUNCTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4549

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 0158| 4549| N119| 5076