BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905388 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11221
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 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

    IT WAS INDICATED A REVISION PROCEDURE WOULD BE PERFORMED. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED INCREASED THRESHOLD MEASUREMENTS, AN UNKNOWN CHANGE IN IMPEDANCE MEASUREMENTS, AND OVERSENSING LESS THAN ONE SECOND. A REVISION PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383451 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 0148| T177