BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3043346 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-04509
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE THE DEVICE REMAINS IMPLANTED. 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

    ADDITIONAL INFORMATION WAS RECEIVED THAT A DISC ANALYSIS FOR DEVICE INFORMATION WAS PERFORMED. ANALYSIS INFORMATION SHOWED, THAT MINUTE VENTILATION (MV) WAS IN THE PROCESS OF AUTO-CALIBRATING. ACCELEROMETER (XL) WAS THE ONLY SENSOR PROVIDING ANY RATE DRIVE. DEPENDING UPON THE TYPE OF MOTION, THE DIRECTION, ETC., XL ONLY CAN OVER DRIVE OR UNDER DRIVE PACING. THE ANALYSIS OBSERVED THAT THEY SHOULD HAVE COMMANDED A MANUAL CALIBRATION OR WAITED FOR THE AUTOCAL TO COMPLETE. THEY CAN ALSO REVIEW THE MV SENSOR STATUS IN THE MV DETAILS WINDOW, WHERE THE MANUAL CALIBRATION BUTTON IS LOCATED. AN ADDITIONAL DIAGNOSTIC FOR RECORDING MORE THAN 1 LAST CALIBRATION TIMESTAMP MAY ALSO HAVE PROVIDED SOME INFORMATION, NAMELY IF CALIBRATION HAD COMPLETED PREVIOUSLY. THE DIAGNOSTIC DATA SHOWS NO LEAD FAILURES AND THE LAST MEASUREMENT WAS 338 OHMS. INFORMATION FOUND THAT ADDITIONAL PROGRAMMING HAD OCCURED AFTER THE MV WAS ENABLED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S HEART RATE REACHED 160 BEATS PER MINUTE (BPM) DURING MODERATE ACTIVITY. PROGRAMMING WAS EVALUATED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. PROGRAMMING CHANGES FOR OPTIMIZATION WERE PERFORMED. A REQUEST TO PERFORM A SAVE TO DISC FOR ANALYSIS WAS DISCUSSED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146268 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K172

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 1882TC| K172