BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3080971 · Received April 26, 2013

    Report

    Report Number
    2124215-2013-06999
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    June 14, 2010
    Report Date
    May 7, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS EVENT WILL BE FURTHER UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHANGE OUT, THIS RIGHT VENTRICULAR LEAD HAS EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. IT HAD BEEN PREVIOUSLY REPORTED THAT THE SHOCK IMPEDANCE VALUES ON THIS LEAD WERE EXHIBITING MEASUREMENTS ON AN UPWARD TREND; HOWEVER, NOT IN A REPORTABLE RANGE. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE HAS BEEN CALLED TO FURTHER INVESTIGATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND TO DATE, NO CHANGE OF PRODUCT STATUS HAS BEEN REPORTED.

    Description of Event or Problem · 1

    FOLLOW-UP WITH THE BOSTON SCIENTIFIC REPRESENTATIVE CONFIRMED THE LEAD REMAINS ACTIVE WITH NO INTERVENTION PLANNED TO DATE. THE PHYSICIAN PERFORMED DEFIBRILLATION TESTING (DFT) WITH SUCCESSFUL SHOCK CONVERSION OBSERVED. A LEAD INTEGRITY ISSUE IS SUSPECTED AND REPLACEMENT NOT PLANNED AT THIS TIME DUE TO THE PATIENT'S RESISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182109 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR H177| 0185