BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1953657 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24078
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    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

    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 DURING A DEVICE REPLACEMENT PROCEDURE, THIS TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED INCREASED SHOCK IMPEDANCES WITH THE NEW DEVICE. TECHNICAL SERVICES (TS) DISCUSSED SEVERAL TROUBLESHOOTING OPTIONS, WHICH WERE NOT SUCCESSFUL. THE PHYSICIAN ELECTED TO REPLACE THE DEVICE. HIGH SHOCK IMPEDANCES WERE AGAIN NOTED WITH THE NEXT DEVICE, THUS THE ISSUE WAS ALLEGED TO BE DUE TO A LEAD ISSUE. THE LEAD WAS SURGICALLY CAPPED AND REPLACED. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    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 51 YR E110| 4470| T165| 0185