BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904378 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-08868
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 10, 2014
    Report Date
    April 10, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PATIENT WAS RECENTLY PLACED IN THE INTENSIVE CARE UNTIL DUE TO LOSS OF CAPTURE (LOC). THE PATIENT WAS THEN STABILIZED AND A BOSTON SCIENTIFIC SALES REPRESENTATIVE WAS CALLED TO INTERROGATE THE DEVICE. ATTEMPTS TO CONTACT THE BSC SALES REPRESENTATIVE HAVE RETURNED NO INFORMATION REGARDING THIS PATIENT. IT IS UNKNOWN HOW LONG THE LOC LASTED. THE DEVICE SYSTEM REMAINS IMPLANTED. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383779 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR N119| 4592| 4470| 0184