BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1950456 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22431
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 18, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S GENERATOR HAD BEEN EMITTING TONES. IT WAS DISCOVERED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD SHOCKING IMPEDANCE MEASUREMENTS LESS THAN 20 OHMS. THE IMPEDANCE MEASUREMENTS WERE ABLE TO BE REPRODUCED IN THE CLINIC. NO SHOCK THERAPY HAD BEEN DELIVERED RECENTLY. TECHNICAL SERVICES (TS) DISCUSSED ISSUE AT HAND AND STATED THAT THE PATIENT IS CONSIDERED UNPROTECTED UNTIL THE ISSUE IS RESOLVED. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE AND THE RV LEAD WAS SURGICALLY CAPPED AND A NEW LEAD WAS PLACED. NO REPORT THAT A SHOCK WAS DELIVERED INTO THE POSSIBLE SHORTED LEAD. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 62 YR Required Intervention H215| 0185| 4087| 4525