BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 2050336 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03033
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A REVISION PROCEDURE. THE REPRESENTATIVE REPORTED THAT THE RIGHT VENTRICULAR SETSCREW WAS LOOSE AND THE PHYSICIAN ADMITTED THAT THE SETSCREW MUST NOT HAVE TIGHTENED APPROPRIATELY AT INITIAL IMPLANT. THE LEFT VENTRICULAR IMPEDANCES WERE OUT OF RANGE BECAUSE OF EXTENDED BIPOLAR PROGRAMMING. THE RIGHT VENTRICULAR SETSCREW WAS TIGHTENED AND VALUES NORMALIZED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT WAS SCHEDULED FOR A LEAD REVISION. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), LEFT AND RIGHT VENTRICULAR LEADS DEVELOPED FATIGUE. UPON FURTHER INVESTIGATION THE PACING IMPEDANCES ON THESE LEADS WERE GREATER THAN 2000 OHMS. THERE WAS INQUIRY OF A CONNECTION ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4518

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 0157| 4087| 4035| H219| 0158| H229| 1298| 4518