BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2124215-2014-12092

    MDR report key: 3904785 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12092
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND FURTHER MONITORED. 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 FOLLOW UP VISIT, INTERROGATION OF THIS PACEMAKER REVEALED THIS PACEMAKER WITH MODEL AND SERIAL NUMBER UNKNOWN WAS OPERATING IN ATRIAL TACHY RESPONSE (ATR) AND MODE SWITCHED TO DDIR PACING MODE RATHER THAN AS PROGRAMMED DDDR. THE PATIENT WITH THIS DEVICE HAS AN UNDERLYING ATRIAL FIBRILLATION RHYTHM. DEVICE LONGEVITY WAS ONE AND ONE-HALF YEARS AT ELECTIVE REPLACEMENT NEAR (ERN) DURING THE FOLLOW-UP. THE DEVICE WAS REPROGRAMMED TO VVI. LONGEVITY REMAINING CHANGED TO FOUR AND ONE-HALF YEARS. THERE WAS CONCERN REGARDING THIS LONGEVITY CHANGE. RATE RESPONSIVE PACING WAS PROGRAMMED OFF. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED REGARDING THE LONGEVITY CHANGE. TS COULD NOT DETERMINE THE REASON DUE TO LACK OF INFORMATION. DEVICE DATA WAS REQUESTED. IN ADDITION, INTENSIFIED FOLLOW-UP WAS RECOMMENDED AS THE DEVICE HAD REACHED ERN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383423 NVZ GUIDANT PUERTO RICO BV BRADY DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1