BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780605 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12974
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DURING A RECENT FOLLOW UP VISIT, IT WAS NOTED THAT THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING A HIGH OUT OF RANGE SHOCKING IMPEDANCE OF GREATER THAN 125 OHMS. THE PATIENT STATED THAT THEY FELL A FEW WEEKS BACK AND BROKE THEIR ARM, THAT IS WHEN THE RISE IN IMPEDANCES WAS SEEN TO HAVE STARTED. THIS FALL WAS DETERMINED TO BE AN ACCIDENT, AND NOT RELATED TO DEVICE FUNCTION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED PERFORMING A COMMANDED TEST ON THE LEAD BY ADMINISTERING BOTH A 1.1 AND A 41 JOULE SHOCK WHICH WILL INDICATE IF THERE IS A LEAD ISSUE PRESENT. THEY PHYSICIAN IS AWARE OF THE RECOMMENDATIONS AND WILL SCHEDULE A FOLLOW UP VISIT IN THE FUTURE AND CONSIDER TESTING AT THAT TIME. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 0185| T175| E141