BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2 LVA DUAL ELECTRODE IS-1 PASSIVE 90CM

    MDR report key: 1605752 · Received February 10, 2010

    Report

    Report Number
    2124215-2010-00016
    Event Type
    Malfunction
    Date Received
    February 10, 2010
    Date of Event
    December 17, 2009
    Report Date
    June 25, 2010
    Manufacturer
    CPI PLANT - ST. PAUL
    Product Code
    OJX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS DISPOSED OF BY THE HOSPITAL STAFF AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES IN (B)(6) 2009 TO REPORT THAT ALL LEAD DIAGNOSTIC MEASUREMENTS FROM THE LAST IN-CLINIC FOLLOW-UP IN (B)(6) 2009 WERE NORMAL. IN (B)(6) 2009, THE LEFT VENTRICULAR (LV) PACING IMPEDANCE MEASUREMENT WAS RECORDED AT GREATER THAN 2000 OHMS. PRIOR TO THAT MEASUREMENT, THE LV PACING IMPEDANCE MEASUREMENTS WERE IN THE 800-900 OHM RANGE. AT THAT TIME, THE LV CONFIGURATION HAD BEEN PROGRAMMED TO LV (TIP) TO LV (RING). THE PACING THRESHOLDS HAVE NOW CHANGED FROM 0.8 VOLTS AT 1.0 MS TO NO CAPTURE. TECHNICAL SERVICES WAS INFORMED THAT THE LV PACING CONFIGURATION WAS REPROGRAMMED TO LV (TIP) TO RV (COIL). SUBSEQUENTLY, THE PACING IMPEDANCE WAS 392 OHMS AND THE PACING THRESHOLD WAS 0.4 VOLTS AT 1.0 MS. TECHNICAL SERVICES CONFIRMED THAT ALL OTHER LEAD DIAGNOSTIC MEASUREMENTS WERE NORMAL FOLLOWING REPROGRAMMING OF THE LV LEAD. SUBSEQUENTLY, BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS LEAD WAS EXPLANTED DUE TO LEAD FRACTURE IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 LVA DUAL ELECTRODE IS-1 PASSIVE 90CM IMPLANTABLE LEAD OJX CPI PLANT - ST. PAUL 4543 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR