BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911844 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00616
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 28, 2012
    Report Date
    September 28, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE FIELD REPRESENTATIVE STATED THAT THE PHYSICIAN OPTED TO NOT BRING THE PATIENT IN FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER REMOTE HOME MONITORING ALERT WAS GENERATED FOR FURTHER INTERMITTENT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE PHYSICIAN PLANS TO BRING THE PATIENT IN FOR TESTING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16324 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR E110| 4470| 0181