BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3040784 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01806
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    PMA / PMN Number
    D970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS IN THE POSSESSION OF THE 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 THIS PACEMAKER REACHED END OF LIFE (EOL) THREE YEARS POST IMPLANT. IT WAS REPORTED THAT THE DEVICE HAD BEEN PROGRAMMED TO A HIGH OUTPUT AT IMPLANT AND THE PATIENT HAD BEEN LOST TO FOLLOW UP. THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143388 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S402

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| L| R 4135| 4554| S402| 4136