BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913237 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00303
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    January 17, 2013
    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 DEVICE SYSTEM DETECTED INCREASED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. ADDITIONAL INFORMATION WAS SOUGHT FROM THE LOCAL AREA SALES REPRESENTATIVE, HOWEVER, AT THIS TIME, ADDITIONAL INFORMATION WAS NOT AVAILABLE. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE INCREASED SHOCK IMPEDANCE MEASUREMENTS CONTINUED. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR FURTHER REVIEW, AND IT WAS FOUND THAT THE PATIENT WAS HAVING COMPLICATIONS WITH THE PRESCRIBED MEDICATION. THE PHYSICIAN BELIEVED THIS TO BE THE CAUSES OF THE OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PHYSICIAN WAS ELECTING TO CONTINUE TO MONITOR THE DEVICE SYSTEM UNTIL THE PATIENTS COMPLICATIONS SUBSIDED. AN IN OFFICE TEST WAS PERFORMED AND ALL MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS. ALL CONFIGURATIONS WERE CHECKED, AND THE DEVICE WAS LEFT IN THE TRIAD CONFIGURATION. THE PATIENT WAS TO HAVE A FOLLOW UP APPOINTMENT THE FOLLOWING MONTH. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20693 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 4087| N118| 0184| 4517| H215