BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053166 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04573
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 10, 2013
    Report Date
    April 1, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE FIELD REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TO REVIEW THE PATIENT'S DATA AND FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD ALSO HAD DECREASING AMPLITUDE MEASUREMENTS. TS DISCUSSED TROUBLESHOOTING OPTIONS ONCE THE PATIENT WAS BROUGHT INTO THE OFFICE. IT WAS ALSO NOTED THAT THE PATIENT HAD BEEN STARTED ON A NEW MEDICATION AROUND THE TIME OF THE SHOCK IMPEDANCE INCREASE AND THAT THE MEDICATION HAD SINCE BEEN STOPPED. TS ADVISED THE FIELD REPRESENTATIVE TO HAVE THE PHYSICIAN CONTACT THE MANUFACTURER OF THE MEDICATION TO DETERMINE ANY RELATED SIDE EFFECTS. ANOTHER ALERT WAS ALSO GENERATED BY THE REMOTE HOME MONITORING SYSTEM ELEVEN DAYS LATER. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN FURTHER INFORMATION FROM THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER ALERT FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS REPORTED. THE FIELD REPRESENTATIVE STATED THE CAUSE OF THE RISE IN IMPEDANCE WAS DETERMINED TO BE DUE TO THE MEDICATION AND ALL VALUES HAVE RETURNED TO NORMAL AND NO FURTHER TESTING WAS PERFORMED. THERE WAS ALSO RISES NOTED IN THE RIGHT ATRIAL (RA), LEFT VENTRICULAR (LV) AND RV PACING IMPEDANCE, HOWEVER NONE WERE OUT OF RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE FIELD REPRESENTATIVE IS ATTEMPTING TO OBTAIN ADDTIONAL INFORMATION FROM THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154187 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 0185| 4517| N118| H179| 4087