BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2050459 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03061
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 1, 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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE HEX DUMP ANALYSIS CONCLUDED THAT THE PARAMETER ERROR WAS SUCCESSFULLY RESET. IT WAS CONFIRMED THE DEVICE WAS OPERATING NORMALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE DAY AFTER IMPLANT, THIS DEVICE WAS EXHIBITING LOSS OF CAPTURE AND AN ERROR MESSAGE. IT WAS CONCLUDED THAT THE PARAMETER ERROR PUT THE DEVICE BACK INTO SHIP MODE WHICH IS DOO 30PPM. THE ERROR WAS CLEARED AND THE DEVICE RESUMED NORMAL FUNCTIONALITY. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS PATIENT EXPERIENCED A SYNCOPAL EPISODE. THE DEVICE APPEARED TO BE FUNCTIONING APPROPRIATELY. A HEX DUMP WAS PERFORMED AND WILL BE SENT IN FOR REVIEW.

    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 Life Threatening