BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1781685 · Received August 3, 2010

    Report

    Report Number
    2124215-2010-14692
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    May 14, 2010
    Report Date
    May 14, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, ALL INFORMATION INDICATES THAT THIS LEAD REMAINS IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED SHOCK IMPEDANCES OF LESS THAN TWENTY OHMS IN INITIAL TRIAD CONFIGURATION. ADDITIONAL SHOCK IMPEDANCE MEASUREMENTS WERE TAKEN IN THE TWO OTHER CONFIGURATIONS AND WERE WITHIN APPROPRIATE RANGE. IT WAS SUSPECTED BY THE PHYSICIAN THAT THE PATIENT'S LEFT VENTRICULAR ASSIST DEVICE WAS INTERFERING WITH THE MEASUREMENTS. THE PHYSICIAN WAS CONFIDENT IN THE LEAD INTEGRITY AND MEASUREMENTS. 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 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR E102| 0184