BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 2522345 · Received April 9, 2012

    Report

    Report Number
    2124215-2012-03234
    Event Type
    Injury
    Date Received
    April 9, 2012
    Date of Event
    February 29, 2012
    Report Date
    February 29, 2012
    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

    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 THIS PACEMAKER WAS EXPLANTED AS A RESULT OF AN INFECTION. THE PACEMAKER WILL BE USED OFF LABEL AS AN EXTERNAL TEMPORARY PACER UNTIL THE INFECTION CLEARS. THE PATIENT WILL BE HOSPITALIZED UNTIL THE INFECTION CLEARS AND NEW IMPLANTS ARE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTRUA NVZ GUIDANT CRM CLONMEL IRELAND S606

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| L| R 1298| S606| 5076