BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913680 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00372
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 28, 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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS AND THERE WAS ALSO A SLIGHT INCREASE FROM 500'S TO 700 OHMS. THE PATIENT WAS EVALUATED IN THE CLINIC AND SEVERAL COMMANDED TESTS WERE PERFORMED RETURNING IMPEDANCE MEASUREMENTS OF 122, 123, AND 124 OHMS. THERE WAS NO NOISE ON THE RV OR SHOCK CHANNELS. THE PATIENT WAS RECENTLY HOSPITALIZED FOR RECEIVING SHOCKS FOR VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF). THE IMPEDANCES WITH SHOCK DELIVERY OF 31 AND 41 JOULE SHOCKS WERE 78-80 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) HAD THE CLINICIAN DO SOME PROVOCATIVE MANEUVERS AND NO NOISE WAS ABLE TO BE PRODUCED AND THE SHOCK IMPEDANCE REMAINED 112 -124 OHMS WITH ARM MOVEMENTS. IT WAS REPORTED THAT THE CLINICIAN FELT THAT THE LEAD WAS OKAY AND WAS GOING TO SEND THE PATIENT HOME AND PERFORM A REMOTE INTERROGATE AT A LATER DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19970 ENDOTAK RELIANCE IMPLANTABLE LEADS NVY CPI - DEL CARIBE 0182

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR E102| 0182