BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910842 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15612
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD MEASUREMENTS HAVE INCREASED GRADUALLY. NO NOISE OR OUT OR RANGE IMPEDANCE MEASUREMENTS HAVE BEEN OBSERVED. AN X-RAY WAS PERFORMED AND REVEALED AN UNDERINSERTION OF THE RV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18414 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 0158| 4096| 4517| H195