BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213710 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09928
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED AN OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE ISSUE (UNKNOWN VALUE). THE PATIENT WAS COMPLAINING OF SHORTNESS OF BREATH (SOB) HOWEVER THE HEALTHCARE PROFESSIONAL (HCP) THOUGHT IT WAS NOT RELATED TO THE PACING IMPEDANCE. TS DISCUSSED THAN AN OOR MAY HAVE HAPPENED BUT IT WAS JUST NOT SHOWING UP IN THE DAILY MEASUREMENTS. TS FURTHER DISCUSSED THAT IT WOULD BE ON THE PHYSICIAN¿S DISCRETION AND MAY CONSIDER BRINGING THE PATIENT IN FOR EVALUATION. ADDITIONAL INFORMATION INDICATED THAT THERE WAS NO INTERVENTION PERFORMED AT THIS TIME AND WILL CONTINUE TO MONITOR THE PATIENT. THIS DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312198 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR N140| 4543| 0292| MISMATCH