BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 2

    MDR report key: 3951176 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-13197
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    April 1, 2014
    Report Date
    July 17, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED THE LEAD CATHODE AND ANODE CONDUCTOR COILS ARE FRACTURED APPROXIMATELY 394 MM FROM THE TERMINAL PIN. EVALUATION OF THE LEAD CONFIRMED THE FRACTURE LOCATION APPEARS TO BE NEAR THE DISTAL END OF THE SUTURE SLEEVE TIE DOWN SITE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED NO CAPTURE AND HIGH, OUT OF RANGE PACING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) ASKED FOR LV LEAD CONFIGURATIONS. THE FIELD REPRESENTATIVE RETESTED IMPEDANCE AND GOT HIGH, OUT OF RANGE MEASUREMENTS IN ALL LV CONFIGURATIONS. NO FURTHER INFORMATION WAS RECEIVED. AS OF THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED STATING THAT HIGH PACING THRESHOLD MEASUREMENT WAS ALSO OBSERVED ON THIS LV LEAD. A SURGICAL REVISION WAS DONE WHERE THE LEAD WAS TESTED ON A PACING SYSTEM ANALYZER (PSA) AND YIELDED THE SAME OUT OF RANGE MEASUREMENT. NO LEAD AND HEADER CONNECTION ISSUE WAS OBSERVED. THE LEAD AND DEVICE WERE EXPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428009 EASYTRAK 2 IMPLANTABLE LEAD NIK CPI - DEL CARIBE 4543

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 4543| N119| 0185