BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1946078 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20097
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, AFTER POSITIONING THIS RIGHT VENTRICULAR LEAD, ABNORMAL MEASUREMENTS WERE OBTAINED. HIGH OUT OF RANGE IMPEDANCE AND INCREASED THRESHOLD MEASUREMENTS WERE OBTAINED. THE LEAD WAS REPOSITIONED SEVERAL TIMES. SIMILAR MEASUREMENTS WERE OBTAINED. A FURTHER REPOSITION ATTEMPT REVEALED ACCEPTABLE MEASUREMENTS; THE LEAD WAS SECURED. POST PROCEDURE, ACCEPTABLE MEASUREMENTS WERE OBTAINED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0286

    Patients

    Seq Age Sex Outcome Treatment
    1