BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041799 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01954
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 12, 2011
    Report Date
    February 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AVAILABLE INFORMATION SUGGESTS THE LEAD REMAINS IMPLANTED WITH NO FURTHER COMPLICATIONS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ANOTHER APPOINTMENT WAS SCHEDULED TO FURTHER EVALUATE THE SYSTEM, WHICH CURRENTLY REMAINS IMPLANTED. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED A RED ALERT THROUGH THE LATITUDE PATIENT MONITORING SYSTEM THAT THIS RIGHT VENTRICULAR (RV) HAD A HIGH RIGHT VENTRICULAR (RV) PACING IMPEDANCE. A FOLLOW-UP APPOINTMENT WAS PERFORMED, AND X-RAYS NOTED NO SIGNS OF LEAD DAMAGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT REVIEWED A COPY OF DEVICE MEMORY. THE REVIEW NOTED THE SYSTEM HAD INTERMITTENT HIGH MEASUREMENTS AFTER APPROXIMATELY ONE YEAR OF IMPLANT, AND THEN PROGRESSIVELY INCREASED OUT OF RANGE. TS RECOMMENDED FURTHER INVESTIGATION. A REVISION PROCEDURE WAS PERFORMED. DURING THE REVISION, IT WAS REPORTED THE LEAD WAS NOT FULLY INSERTED INTO THE DEVIC HEADER. WHEN MOVING THE LEAD NEAR THE HEADER, THE DEVICE MEASURED OUT OF RANGE IMPEDANCE. LEAD MEASUREMENTS PERFORMED ON A PACING SYSTEM ANALYZER FOUND NO OUT OF RANGE MEASUREMENTS. THE RELATED DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention