BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2161546 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07629
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 17, 2011
    Report Date
    May 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT WAS SEEN FOR FOLLOW UP. A 1.1 JOULE COMMANDED SHOCK WAS DELIVERED WHICH RESULTED IN AN IMPEDANCE OF 37 OHMS AND A 41 JOULE COMMANDED SHOCK WAS DELIVERED WHICH RESULTED IN AN IMPEDANCE OF 36 OHMS. THE SYSTEM WILL CONTINUE TO BE MONITORED. NO CHANGES WERE MADE AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A LATITUDE RED ALERT THAT THIS RIGHT VENTRICULAR (RV) LEAD AND DEVICE DISPLAYED A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. TECHNICAL SERVICES RECOMMENDED PERFORMING SOME TROUBLE SHOOTING. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE SYSTEM REMAINS IN SERVICE.

    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 45 YR Required Intervention E110| 4136| 0185