BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2163311 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07327
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    May 26, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS LEAD REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS AND INCREASED THRESHOLD MEASUREMENTS OF 2.5 VOLTS. TECHNICAL SERVICES (TS) SUGGESTED PERFORMING LOW AND MAXIMUM ENERGY SHOCKS TO CHECK THE LEAD CONNECTION. ADDITIONAL INFORMATION INDICATED AN XRAY WAS NOT PERFORMED. THE DEVICE WAS REPROGRAMMED TO TAKE THE PROXIMAL COIL OUT OF THE CONFIGURATION WHICH RESULTED IN NORMAL IMPEDANCES. THE FIELD REPRESENTATIVE SUSPECTS THE ISSUE TO BE WITH THE PROXIMAL PORT SETSCREW. HE INDICATED THAT DFT'S WOULD BE PERFORMED TO TEST THE NEW PROGRAMMING. IF IT DID NOT WORK, A REVISION WOULD BE SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THIS LEAD WAS SURGICALLY ABANDONDED FOR AN UNKNOWN REASON.

    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 66 YR 4135| 0184| E110