BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 2171548 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09874
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE BELIEVED THE INCISION LOCATION WAS INFECTED. THERE WAS A STRING COMING OUT OF THE INCISION. THE INCISION IS RED AND WHEN THE INCISION IS PRESSED ON, BODILY FLUIDS COME OUT. THE PATIENT'S PHYSICIAN IS AWARE OF THE STRING AND INFORMED THE PATIENT THAT IT WILL GO AWAY. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    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 53 YR S603| 4473| 4472