BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053289 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04006
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 14, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    NEW INFORMATION BECAME AVAILABLE THAT A REVISION PROCEDURE WAS DONE IN WHICH THE LEAD WAS REMOVED FROM THE DEVICE HEADER AND THEN RECONNECTED ONCE AGAIN. PRIOR TO REMOVING THE LEAD FROM THE DEVICE HEADER, THE PHYSICIAN GAVE THE LEAD A TUG TO ENSURE AN ADEQUATE CONNECTION, THE LEAD WAS SECURE WITHIN THE HEADER. ONCE THE LEAD WAS REINSERTED INTO THE DEVICE HEADER, ALL NUMBERS ARE NOW WITHIN AN ACCEPTABLE RANGE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXHIBITING FLUCTUATING IMPEDANCE MEASUREMENTS, RANGING FROM 1200 TO GREATER THAN 2000 OHMS SINCE IMPLANT. THERE WERE ALSO SOME THRESHOLD ISSUES. SOME PROGRAMMING CHANGES WERE MADE TO ALLEVIATE THESE ISSUES. THE DECISION WAS MADE TO REVISE THIS LEAD IN THE COMING DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other T135| 0147| E102