BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911316 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16249
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 24, 2012
    Report Date
    November 24, 2012
    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 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 THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT INTO THE OFFICE FOR EVALUATION AND ISOMETRICS WERE PERFORMED. THE SHOCK IMPEDANCE MEASUREMENT DID INCREASE AND A SMALL AMOUNT OF NOISE WAS NOTED ON THE SHOCK ELECTROGRAM (EGM) WITH ISOMETRICS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED PERFORMING INDUCTION TESTING. THE FIELD REPRESENTATIVE DISCUSSED THE OPTIONS WITH THE PHYSICIAN. HOWEVER THE PHYSICIAN OPTED TO NOT PERFORM INDUCTION TESTING AND WILL MONITOR THE SITUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18028 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0138

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 4549| 4542| 0138| N119| 4470