BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 3904802 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09037
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 16, 2014
    Report Date
    June 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. A CHECK LEAD ALERT WAS OBSERVED DURING A FOLLOW UP VISIT INTERROGATION. AN INTERNAL TECHNICAL SERVICE CONSULTANT REVIEWED THE DATA. SENSING AMPLITUDES HAVE BEEN VARIABLE. NO OUT OF RANGE IMPEDANCE MEASUREMENTS WERE FOUND IN THE DAILY TREND GRAPH. LEAD INTEGRITY VERIFICATION WAS RECOMMENDED. IT WAS THOUGHT THE ISSUE COULD ALSO BE DUE TO THE SENSING AMPLITUDE VARIABILITY AND IMPEDANCE MEASUREMENTS MAY BE ACCEPTABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    DESPITE ATTEMPTS, NO FURTHER INFORMATION COULD BE OBTAINED REGARDING FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382334 ENDOTAK ENDURANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0154

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR F110| 0154| 432-35S-52