BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3052725 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05147
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    May 10, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SYSTEM WAS REPLACED AT ANOTHER FACILITY. A NEW SYSTEM WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE. THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS NOT AWARE OF ANY FURTHER INFORMATION. AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. SHOULD THIS DEVICE GET RETURNED AT A LATER TIME, THIS REPORT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED OBSERVATIONS OF OVERSENSING AND PACING INHIBITION AS THIS DEVICE PASSED ALL TESTING DURING ANALYSIS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE MEMORY CONFIRMED THERE WERE NO RESETS OR MEMORY ERRORS LOGGED. THE AUTO-CAPTURE FEATURE WAS PROGRAMMED OFF WHEN THE SAVE TO DISK WAS PERFORMED. IT APPEARS THE DEVICE HAD AUTO-CAPTURE PROGRAMMED ON AND OFF A FEW TIMES WHICH CAUSED CONFUSION IN THE DAILY MEASUREMENTS REPORTS. ENGINEERING NOTED THE LAST AUTO-THRESHOLD TEST FAILED DUE TO EVOKED RESPONSE NOISE. A REVIEW OF THE DEVICE PROGRAMMING SHOWED THE VENTRICULAR SENSITIVITY WAS SET FROM 3.0 MV TO 10.0 MV. THE ATRIAL SENSITIVITY WAS SET TO 0.5 MV. THE DEVICE OUTPUTS WERE PROGRAMMED TO 1.5 V AT 0.4 MS. THE AV DELAY WAS SET TO DYNAMIC AT 140-200 MS. THE LOWER RATE LIMIT WAS SET AT 75 PPM, THE MAX TRACKING RATE WAS SET AT 100 PPM AND THE MAX SENSOR RATE WAS SET AT 115 PPM. ATRIAL TACHY RESPONSE WAS SET TO A 0 DURATION WITH A TRIGGER RATE OF 120 BPM AND A MODE SWITCH OF VDIR. BASED ON REVIEW OF THE DEVICE MEMORY, THE DEVICE APPEARED TO BE FUNCTIONING PROPERLY. BOSTON SCIENTIFIC ENGINEERING SUGGESTED STARTING OVER WITH PROGRAMMING NOMINAL SETTINGS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH A PACEMAKER WAS ADMITTED TO THE HOSPITAL WITH SYMPTOMS OF DIZZINESS.OVERSENSING AND PACING INHIBITION WAS OBSERVED IN THE RIGHT VENTRICLE (RV) WHICH SEEMED TO CORRELATE WITH ATRIAL SENSED EVENTS. ISOMETRICS AND POCKET MANIPULATION WERE PERFORMED WHICH COULD NOT RE-CREATE THE ISSUE. THE PATIENT HAS NO UNDERLYING RHYTHM SO IS DEPENDENT ON PACING. PRIOR TESTING PERFORMED ON THE PATIENT CONFIRMED MILD ELEVATED ENZYMES AND SLIGHTLY ABNORMAL ELECTROLYTES. IT WAS NOTED THAT THE PATIENT DOESN'T COMPLAIN MUCH ABOUT SYMPTOMS, HOWEVER DOES EXHIBIT SYMPTOMS WHEN PACING THRESHOLD TESTING IS DONE. A FREE RUNNING 12-LEAD EKG WAS THEN TAKEN AND SHOWED ISOELECTRIC PREMATURE VENTRICULAR CONTRACTIONS. A LEAD CHECK CONFIRMED NORMAL DIAGNOSTICS; HOWEVER, NOISE WAS PRESENT ON BOTH CHANNELS BUT WAS NOT BEING SENSED. PATIENT TRIGGERED ELECTROGRAMS DETERMINED THE EVENTS WERE OCCURRING WHILE THE PATIENT WAS IN A SITTING OR LYING DOWN POSITION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) TROUBLESHOOTING EFFORTS AND ATTEMPTS MADE TO REPROGRAM AROUND THE ISSUE WERE UNSUCCESSFUL. THE PATIENT IS BEING EVALUATED FOR A POSSIBLE RV LEAD REVISION AND PACEMAKER REPLACEMENT. A SAVE TO DISK WAS PERFORMED AND SENT TO BOSTON SCIENTIFIC ENGINEERING FOR REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155469 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L 4088| 4470| S606