BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052697 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04258
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN WILL CONTINUE TO MONITOR THE DEVICE AND LEAD. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. IT WAS NOTED THAT THE PATIENT RECENTLY UNDERWENT BONE STIMULATOR INTERACTION TESTING. IT WAS SUSPECTED THAT THE OUT OF RANGE MEASUREMENTS WERE DUE TO THE TESTING. NO ADDITIONAL OUT OF RANGE MEASUREMENTS WERE OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154739 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR E102| 0184