BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140205 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16754
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 30, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION WAS AVAILABLE FROM THE FIELD. THE AVAILABLE EVIDENCE SUGGESTS THAT THIS LEAD REMAINS IN-SERVICE. 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 LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). ACCRODING TO THE LOCAL REPRESENTATIVE, THE RIGHT VENTRICULAR (RV) PACING IMPEDANCE AND RV PACING THRESHOLDS WERE 1000 OHMS AND LESS THAN 1.0 VOLT AT 0.5 MS RESPECTIVELY. ONE DAY FOLLOWING THE IMPLANT PROCEDURE, THE RV PACING IMPEDANCE WAS 2500 OHMS AND THE RV PACING THRESHOLD WAS 6.0 VOLTS AT 2.0 MS. NO ELECTROGRAM NOISE WAS IDENTIFIED. THE PATIENT IS NOT PACEMAKER DEPENDENT AND THE DFT TEST WAS SUCCESSFUL AT 21 JOULES. TS DISCUSSED THE POSSIBILITY OF A PERFORATION OR MICRODISLODGEMENT. BASED ON THE ABSENCE OF PACEMAKER DEPENDENCY, THE PHYSICIAN COULD CONTINUE MONITORING OR A RV LEAD REVISION COULD BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619552 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 4136| 0296| D022