BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2170358 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-10885
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 3, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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. 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.

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS EXPLANTED (B)(6) MONTHS LATER FOR NORMAL BATTERY DEPLETION AND RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE PACEMAKER CHECK FOR THIS PACEMAKER DEPENDENT PATIENT, THE DEVICE WAS NOTED TO BE IN AUTOMATIC CAPTURE RETRY AT 5.0V, DUE TO INCREASED VENTRICULAR THRESHOLD MEASUREMENTS. VENTRICULAR SENSING AND IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS, AS WAS THE ATRIAL THRESHOLD MEASUREMENT. NO PROGRAMMING CHANGES WERE MADE TO THE DEVICE. AFTER TESTING WAS COMPLETED THE PATIENT STATED THAT SHE FELT LIGHTHEADED AND EXPERIENCED SYNCOPE FOR AN UNKNOWN REASON. THE PATIENT WAS TAKEN TO THE HOSPITAL FROM THE CLINIC IN AN AMBULANCE. THE PATIENT CONTACTED PATIENT SERVICES AND ALLEGED THAT THE EMERGENCY ROOM PHYSICIAN TOLD HER THAT THE DEVICE TESTING WENT TOO LONG, WHICH MAY HAVE CONTRIBUTED TO HER SYNCOPE. THE PATIENT STATED THAT THE EMERGENCY ROOM PHYSICIAN TOLD HER THERE WAS NO ISSUES WITH HER DEVICE AND SHE WAS RELEASED. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE (SR) STATED SHE WAS UNAWARE OF THE OUTCOME OF THIS PATIENT AND HAD DISCUSSED WITH THE PHYSICIAN THAT NO PROGRAMMING CHANGES WERE MADE TO THE DEVICE AND THE FOLLOW-UP WAS COMPLETELY DONE WHEN THE PATIENT EXPERIENCED THE SYNCOPE. NO EPISODES WERE RECORDED IN THE DEVICE AND NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE PACEMAKER SYSTEM REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)