BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 3212554 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09603
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THIS PATIENT PRESENTED TO THE EMERGENCY ROOM FOR A PROCEDURE UNRELATED TO THEIR PACEMAKER. WHEN THE PATIENT WAS TURNED THEIR HEART RATE INCREASED TO 120 BPM. THE PHYSICIAN BELIEVED THIS TO BE DUE TO THE DEVICE'S RATE RESPONSE AND PLACED A MAGNET OVER THE DEVICE AND THEIR RATE DECREASED TO 100 BPM. HOWEVER, THE PATIENT WAS NOTED TO HAVE A STENOTIC VALVE AND THE PHYSICIAN DID NOT BELIEVE THE PACING RATE TO BE APPROPRIATE. UPON REMOVING THE MAGNET, THE DEVICE EXHIBITED INTERMITTENT LOSS OF CAPTURE. THE PACEMAKER WAS ALSO REPORTED TO BE LOOSE IN THE DEVICE POCKET AND THE LOSS OF CAPTURE WAS INTERMITTENTLY REPRODUCIBLE WITH POCKET MANIPULATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED THE MAGNET RATE OF THE DEVICE WAS NORMAL FOR THE AGE OF THE DEVICE AND RECOMMENDED THE PHYSICIAN HAVE THE DEVICE INTERROGATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE INDICATING THE MINUTE VENTILATION (MV) SENSOR WAS INTERACTING WITH THE MONITORING EQUIPMENT CAUSING THE DEVICE TO PACE AT ITS MAXIMUM TRACKING RATE (MTR) OF 120 BPM. THE MV SENSOR WAS PROGRAMMED OT PASSIVE AND THE ISSUE RESOLVED. IT WAS ALSO NOTED THAT THE AUTO CAPTURE WAS PROGRAMMED ON AND CAUTERY WAS IN USE DURING THE PROCEDURE. AUTO CAPTURE WAS TURNED OFF AND THE DEVICE SET TO A FIXED RIGHT VENTRICULAR (RV) OUTPUT TO PREVENT THE OBSERVED LOSS OF CAPTURE. THERE WAS NO ASYSTOLE GREATER THAN TWO SECONDS REPORTED. THE DEVICE'S RATE RESPONSE WILL BE PROGRAMMED BACK ON AT THE PATIENT'S NEXT CLINIC VISIT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313368 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 1291| MISMATCH