BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2171533 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09940
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 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

    ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN MADE. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED AN ATTEMPT TO COMMUNICATE WITH THE DEVICE WAS UNSUCCESSFUL. A MAGNET RESPONSE WAS UNABLE TO BE OBTAINED. IT WAS REPORTED THE PATIENT WAS BRADYCARDIC AND THERE WAS NO EVIDENCE THAT THE PATIENT EXPERIENCED ASYSTOLE FOR GREATER THAN TWO SECONDS. THE EMERGENCY ROOM (ER) PHYSICIAN PLANNED TO TRANSFER THE PATIENT TO ANOTHER HOSPITAL FOR ANOTHER UNRELATED ISSUE, WHICH WAS THE ORIGINAL REASON THE PATIENT HAD PRESENTED TO THE ER. THE DEVICE ISSUE PLANNED TO BE TAKE ADDRESSED AT THE OTHER HOSPITAL. 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 THE PATIENT WITH THIS PACEMAKER PRESENTED TO THE EMERGENCY ROOM (ER) DUE TO THEIR DEVICE NOT PROVIDING PACING THERAPY. THE DEVICE WAS ATTEMPTED TO BE INTERROGATED BUT WAS UNSUCCESSFUL. A MAGNET RATE HAD NOT YET BEEN ATTEMPTED. THE LOCAL AREA SALES REPRESENTATIVE PLANNED TO ATTEMPT SOME TROUBLESHOOTING OPTIONS. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    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 77 YR 4087| S603| 4469| 1298