BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140464 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-17229
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 18, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD RECORDED A SINGLE LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE PATIENT WAS BROUGHT INTO THE CLINIC AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS AND THERE WAS NO EVIDENCE OF NOISE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED PERFORMING A LEAD INTEGRITY TEST HOWEVER THE PHYSICIAN ELECTED TO MONITOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO INTERVENTION WAS PERFORMED. THE LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619256 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR F102| 0175