BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 2171322 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-10478
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: DUE TO ADDITIONAL INFORMATION THE EVENT DATE AND ALERT DATE WERE UPDATED. ALL AVAILABLE INFORMATION INDICATES THAT THIS DEVICE WAS EXPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS DEVICE REMAINS IN SERVICE. 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 THE PATIENT WITH THIS PRODUCT DISPLAYED SIGNS OF AN EROSION. A LOCAL AREA SALES REPRESENTATIVE CONFIRMED THE PATIENT DID NOT HAVE AN INFECTION, HOWEVER IS PRONE TO INFECTIONS DUE TO AN UNDERLYING BLOOD DISEASE. AN INVASIVE SURGICAL PROCEDURE WAS PERFORMED TO REVISE THE POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    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 66 YR Life Threatening| R 1291| MISMATCH| 4470