BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISCOVERY II

    MDR report key: 1953709 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23923
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 31, 2007
    Report Date
    December 10, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE SHOULD BE RETURNED, THIS EVENT WILL BE REOPENED AND THE DEVICE WILL BE ANALYZED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) CRM RECEIVED INFORMATION THAT THIS BSC SALES REPRESENTATIVE (SR) CALLED TECHNICAL SERVICES (TS) REPORTING THIS PATIENT'S DEVICE WAS PACING AT THE MAXIMUM SENSOR RATE DURING A FOLLOW-UP IN THE CLINIC. THE SR STATED NO RATE ENHANCEMENTS WERE TURNED ON. THE SR ALSO STATED THAT SHE LOWERED RESPONSE FACTOR AND THERE WAS NO CHANGE IN RATE. TS RECOMMENDED TURNING THE RATE RESPONSE FEATURE OFF AND BELIEVES THIS ISSUE IS CONSISTENT WITH THE PDM HERMETIC SEALING ADVISORY, ORIGINAL POPULATION ((B)(6) 2005), WHICH THIS DEVICE IS INCLUDED IN. TS RECOMMENDED REPLACING THE DEVICE SOON. THE SR TURNED OFF THE ACCELEROMETER AND THE PATIENT'S RHYTHM AND RATE MODERATED. FURTHER INFORMATION RECEIVED TWO WEEKS LATER INDICATES THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO THE DEVICE BEING STUCK AT THE MAX TRACKING RATE (MTR). NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISCOVERY II IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1184

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR (B)(4)| (B)(4)