BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1771272 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12235
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 16, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS REPORT, THERE IS NO ADDITIONAL INFORMATION REGARDING THE EXPLANT PROCEDURE. THIS EVENT WILL BE UPDATED SHOULD FURTHER INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT DEVELOPED AN INFECTION. THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL TO HAVE THE ENTIRE PACING SYSTEM REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    WE RECEIVED ADDITIONAL INFORMATION FROM THE BOSTON SCIENTIFIC CRM SALES REPRESENTATIVE (SR) INDICATING THE ENTIRE PACING SYSTEM WAS REMOVED AND REPLACED WITH A COMPETITOR SYSTEM. THE SR CONFIRMED THE EXPLANTED PACING SYSTEM WOULD NOT BE RETURNED AS IT WAS SENT TO HOSPITAL PATHOLOGY FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 4269| 4472| 4285| 1232| 1297| 4473