BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2151464 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-06760
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    February 11, 2011
    Report Date
    April 5, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD MIGRATED. DURING THE REPOSITIONING PROCEDURE, A TUMOR WAS FOUND ON THE DEVICE AND WAS REMOVED. SINCE THE PROCEDURE, THE IMPLANT SITE WAS SORE AND THE PATIENT FELT A BURNING SENSATION. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED AS THE SKIN AROUND THE DEVICE WAS ERODING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1291

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)