BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040758 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01477
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THROUGH A REMOTE MONITORING SYSTEM THAT THIS DEVICE DETECTED AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD. REVIEW OF THE DEVICE INFORMATION INDICATED NORMAL SHOCK LEAD VARIATION BETWEEN 90 AND 120 OHMS WITH THE OCCASIONAL MEASUREMENT GREATER THAN 125 OHMS. IT WAS NOTED THAT THE THRESHOLD MEASUREMENTS WERE HIGH. NO LEAD FRACTURE WAS SUSPECTED; THEREFORE, THE PATIENT WILL BE FOLLOWED APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142990 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0128

    Patients

    Seq Age Sex Outcome Treatment
    1 0148| 0128| F102