BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTRUA

    MDR report key: 3040639 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00569
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 A PATIENT ADVOCATE FOR THE PATIENT IMPLANTED WITH THIS DEVICE REPORTED THAT THE DEVICE WAS NO LONGER FUNCTIONAL AND REMAINS IMPLANTED. IT WAS ALSO NOTED THAT THE PATIENT SUFFERS FROM DEMENTIA. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143730 ALTRUA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR MISMATCH| 4024| 4524| S603