BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1970238 · Received January 25, 2011

    Report

    Report Number
    2124215-2011-01087
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 5, 2010
    Report Date
    February 1, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Additional Manufacturer Narrative · 1

    RECORDS INDICATE THIS LEAD WAS SURGICALLY ABANDONED. 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

    ADDITIONAL INFORMATION INDICATED THIS LEAD WAS CAPPED AND REPLACED WITH ANOTHER MANUFACTURER'S LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE SYSTEM SIGNALED AN ALERT TO THE REMOTE PATIENT MONITORING SYSTEM OF A HIGH RIGHT VENTRICULAR PACING IMPEDANCE. THE IMPEDANCE STARTED RISING IN (B)(6) 2010 AND REACHED GREATER THAN 2000 OHMS ON (B)(6) 2010. THE MEASUREMENT HAS FLUCTUATED SINCE THEN. THE RIGHT VENTRICULAR LEAD WAS IMPLANTED IN 2005 AND DEVICE WAS IMPLANTED IN (B)(6) 2010. NO NOISE WAS OBSERVED. THE INTENTION IS TO FOLLOW-UP WITH THIS PATIENT IN THE NEAR FUTURE. CURRENTLY ALL PRODUCTS REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR T165| 0184| 5076| E110