BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052802 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05507
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 24, 2013
    Report Date
    May 13, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    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

    THE FIELD REPRESENTATIVE WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION RELATED TO THIS OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE HIGH, OUT OF RANGE, PACING IMPEDANCES OF > 2000 OHMS CONTINUED, HOWEVER, THERE WERE NO ISSUES WITH NOISE, OVERSENSING OR HIGH THRESHOLDS ON THIS LEAD. SURGICAL INTERVENTION WAS PERFORMED; THE PACE/SENSE PORTION OF THIS LEAD WAS SURGICALLY ABANDONED, AND A NEW RV PACE/SENSE LEAD WAS SUCCESSFULLY IMPLANTED. THE HIGH VOLTAGE PORTION OF THIS LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS PATIENT'S HOME MONITORING SYSTEM DETECTED HIGH, OUT-OF-RANGE (OOR), PACING LEAD IMPEDANCES FOR THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155079 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR 4470| E110| 0175