BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151666 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07187
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    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.

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION VIA A LATITUDE RED ALERT THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCES. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN MADE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED ANOTHER HIGH OUT OF RANGE SHOCK IMPEDANCE WAS OBSERVED. UPON FOLLOW UP, IT WAS NOTED THAT THE LEAD HAD ALSO DISPLAYED LOW SHOCK IMPEDANCE MEASUREMENTS. TECHNICAL SERVICES DISCUSSED SOME TROUBLE SHOOTING OPTIONS WITH THE LOCAL FIELD REPRESENTATIVE. THE PHYSICIAN REPROGRAMMED THE SHOCK VECTOR TO RV COIL TO CAN AND WILL CONTINUE TO MONITOR THE PATIENT. NO 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 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 10821 DA E102| 0157| 1860