BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 1982801 · Received February 9, 2011

    Report

    Report Number
    2124215-2011-02425
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    December 21, 2010
    Report Date
    March 10, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO DISCUSS THIS EVENT FURTHER. THERE IS UNDERSENSING OF THE P-WAVES BUT THERE IS ALSO FF OVERSENSING AND DOUBLE-COUNTING AT 200. REPROGRAMMING OF THE ATRIAL SENSITIVITY AND PVARP WAS UNDERTAKEN. THERE WERE P-WAVE MEASUREMENTS OF 0.7 MV BUT THERE WAS ALSO MEASUREMENTS OF GREATER THAN 3.0 AND 5.0 MV. THE PATIENT HEART RATE CAN INCREASE TO 144 BPM WHEN HUNCHED OVER ON A BICYCLE WHICH IS FOLLOWED BY A DECREASE IN HEART RATE TO 72 BPM AND FF OVERSENSING. THE PHYSICIAN PLANS TO PERFORM A LEAD REVISION PROCEDURE IN A COUPLE OF WEEKS DUE TO THE POSSIBILITY OF A MICRODISLODGEMENT OF THE COMPETITOR LEAD. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THE PATIENT WAS SEEN AGAIN DUE TO CONTINUED PATIENT SYMPTOMS. THE SENSITIVITY AND REFRACTORY FEATURES WERE REPROGRAMMED BACK TO THE ORIGINAL SETTINGS. THE PHYSICIAN SUSPECTS THAT THE FF OVERSENSING ISSUE IS LIKELY DUE LEAD PLACEMENT. THE PHYSICIAN MAY ALSO IMPLANT A RIGHT VENTRICULAR (RV) LEAD FOR VENTRICULAR SUPPORT AS THE PATIENT HAS SHOWN PERIODS OF HEART BLOCK AT FASTER RATES.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM AN IMPLANT FORM THAT THIS DEVICE WAS ELECTIVELY EXPLANTED IN (B)(6) 2011 DUE TO PATIENT CONDITION. THE PATIENT'S DEVICE WAS UPGRADED FROM A SINGLE-CHAMBER TO DUAL-CHAMBER DEVICE. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY AND IS CURRENTLY UNDERGOING ANALYSIS.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY DETERMINED THAT THE DEVICE HAD NORMAL TELEMETRY OPERATIONS, AS WELL AS NORMAL PACING AND SENSING FUNCTIONS. A REVIEW OF THE DEVICE'S MEMORY REVEALED THAT A RATE FAULT RESET WAS STORED IN THE RESET COUNTER. LABORATORY TESTING HAS SHOWN THAT THE AUTO LEAD DETECT FEATURE CAN CAUSE A RATE FAULT RESET TO OCCUR, DUE TO THE MAX TRACKING RATE PROTECTION NOT BEING INITIALIZED. THIS TYPE OF RESET OCCURS PRIOR TO LEAD ATTACHMENT. ONCE A LEAD IS DETECTED, THE AUTO LEAD DETECT FEATURE WILL BE DISABLED, ALLOWING THE MAX TRACKING RATE PROTECTION TO BE INITIALIZED, PREVENTING THE RATE FAULT RESETS FROM OCCURRING. THIS RESET IS NORMAL DIAGNOSTIC BEHAVIOR AND DOES NOT HAVE ANY IMPACT ON THE THERAPY PROVIDED TO THE PATIENT. THE DEVICE PERFORMED NORMALLY THROUGHOUT ANALYSIS AND WAS FOUND TO BE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT HAS A RESTING HEART RATE OF 35-40 BPM (ATHLETIC PATIENT) AND WAS UNABLE TO PROGRAM A LOWER RATE LIMIT (LRL) OF 50 BPM WITH MINUTE VENTILATION PROGRAMMED ON. TECHNICAL SERVICES DISCUSSED HYSTERESIS AND RATE SMOOTHING. ADDITIONALLY, THE PATIENT HAS EXPERIENCED SINUS PAUSES WHEN THE HEART RATE INCREASES ABOVE 160 BPM. TECHNICAL SERVICES INFORMED THE LOCAL REPRESENTATIVE THAT THE LRL CANNOT BE PROGRAMMED LOWER THAN 50 BPM. TECHNICAL SERVICES DISCUSSED MV AND THE REASONS WHY THE DEVICE COULD NOT BE PROGRAMMED TO LOWER THAN 50 BPM. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REQUEST ELECTROGRAM REVIEW BECAUSE OF POSSIBLE RIGHT ATRIAL FAR-FIELD (FF) SENSING ON THIS COMPETITOR RA LEAD. THE LOCAL REPRESENTATIVE INFORMED TECHNICAL SERVICES THAT THE PATIENT IS FEELING CHEST PRESSURE AND POSSIBLE RA LOSS OF CAPTURE. RA SENSING HAS CHANGED FROM 1.0-5.8 MV TO 1.0-2.0 MV. RA PACING IMPEDANCE AND THRESHOLDS WERE WITHIN NORMAL RANGE. TECHNICAL SERVICES DISCUSSED THE POSSIBILITY OF AN RA LEAD DISLODGEMENT. TECHNICAL SERVICES SUGGESTED THAT A CHEST XRAY BE TAKEN TO VERIFY RA LEAD POSITION. A FAX'ED ELECTROGRAM PRINTOUT WAS RECEIVED AND IN BOTH THE PRESENTING ELECTROGRAM AND STORED EPSIODES, IT APPEARS THAT THE DEVICE MAY NOT BE CAPTURING THE RA. THE LOCAL REPRESENTATIVE DISCUSSED THE POSSIBILITY OF A RA LEAD DISLODGEMENT OR PERFORATION. THE PATIENT IS VERY ACTIVE AND WENT SKIING SHORTLY AFTER THE IMPLANT PROCEDURE. THE LOCAL REPRESENTATIVE REPORTED THAT THERE WAS NO EVIDENCE OF DISLODGEMENT OR PERFORATION BASED ON XRAY AND ECHOCARDIOGRAM. HOWEVER, THE PACING THRESHOLDS HAD INCREASED. THE PATIENT HAS BEEN SCHEDULED FOR FURTHER TESTING INCLUDING MV OPTIMIZATION TESTING. THERE WAS NO CONFIRMED LOSS OF CAPTURE WITH POSSIBLE FAR-FIELD OVERSENSING. THE INABILITY TO INCREASE THIS PATIENT'S HEART RATE STILL REMAIN UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S601

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR 4076| S601