BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 3213110 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10612
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 3, 2013
    Report Date
    July 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 LEFT VENTRICULAR (LV) LEAD EXHIBITED A JUMP IN IMPEDANCE FROM 800 TO OVER 2000 OHMS, WITH SOME INTRINSIC AMPLITUDE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED THAT IMPEDANCE MEASUREMENTS THAT HIGH COULD BE INDICATIVE OF A LEAD FRACTURE, UNKNOWN IF RELATED TO AMPLITUDE, MIGHT BE RELATED TO NOISE. TS SUGGESTED ISOMETRICS AND SOME OTHER TESTS TO DETERMINE LEAD VIABILITY. THE LEAD REMAINS IMPLANTED. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED LOSS OF CAPTURE (LOC) AND THE HEALTH CARE PROFESSIONAL (HCP) CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO SEE ABOUT ELECTRICALLY TURNING THE LEAD OFF TO PRESERVE DEVICE BATTERY. TS ADVISED SOME PROGRAMMING CHANGES THAT COULD BE MADE. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314442 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR N119| 4543| 6947| 7278| 5076