BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYTRAK 3

    MDR report key: 2173366 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10747
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    OJX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE LEAD HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC, CRM FOR ANALYSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF FURTHER INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE LEFT VENTRICULAR (LV) LEAD HAD AN INCREASE IN PACING IMPEDANCE MEASUREMENTS TO 1,600 OHMS. THERE WAS ALSO AN INCREASE IN PACING THRESHOLD MEASUREMENTS AND MUSCLE STIMULATION REPORTED. THE LEAD PLANNED TO BE SURGICALLY ABANDONED DURING THE DEVICE CHANGEOUT PROCEDURE, HOWEVER IT WAS DISCOVERED THAT THE LOCATION THE PHYSICIAN PLANNED TO PLACE THE LV LEAD WAS OCCLUDED. A PROCEDURE WITH A DIFFERENT PHYSICIAN WAS SCHEDULED TO EXTRACT THE LEAD. DURING THE PROCEDURE IT WAS DISCOVERED THAT THE LV LEAD HAD A CONDUCTOR FRACTURE AT THE TIP ELECTRODE. AFTER DISCONNECTING THE LV LEAD, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION WITH THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD. THIS WAS ALSO CONFIRMED WITH THROUGH TESTING WITH THE PACING SYSTEM ANALYZER (PSA). FLUOROSCOPY CONFIRMED BREAKS IN THE LV AND RV LEADS. HOWEVER, THE RV LEAD MEASUREMENTS WERE WITHIN NORMAL RANGE WITH A PACING IMPEDANCE MEASUREMENT OF 480 OHMS, INTRINSIC SENSING AT 17 MV AND PACING THRESHOLDS AT 0.8 V. THE LEADS WERE EXTRACTED AND SUCCESSFULLY REPLACED. THE PATIENT WAS NOT PACEMAKER DEPENDENT AND THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD OJX CPI - DEL CARIBE 4525

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R H175| 0185| H170| 4525| 4136| 4087