BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 1944897 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-19395
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 3, 2010
    Report Date
    October 3, 2010
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE WAS UNDERGOING EMERGENCY MEDICAL ASSISTANCE WHEN IT WAS NOTED THAT THIS DEVICE WAS POSSIBLY NOT WORKING PROPERLY. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. THE SPECIFIC DETAILS OF THE MALFUNCTION WERE NOT PROVIDED AS WELL AS THE SERIAL NUMBER FOR THIS DEVICE IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT PUERTO RICO BV S602

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R