BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1952737 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23828
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    September 27, 2010
    Report Date
    March 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR ANALYSIS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS EXPLANTED APPROXIMATELY FIVE MONTHS LATER DUE TO NORMAL BATTERY DEPLETION (NBD). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE FIELD REPRESENTATIVE NOTED THE DEVICE WAS PROGRAMMED TO HIGH PACING OUTPUTS AND THE BATTERY REMAINING ESTIMATE NOTED LESS THAN SIX MONTHS REMAINING FOR THE LAST ELEVEN MONTHS, WHICH SEEMED LIKE A LONG TIME GIVEN THE PROGRAMMED OUTPUTS. A MEMORY DOWNLOAD WAS PERFORMED AND IT WAS DETERMINED THAT APPROXIMATELY 1.5 MONTHS OF BATTERY LIFE WAS REMAINING. THE PATIENT WAS SCHEDULED FOR A FOLLOW UP IN SIX WEEKS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1296

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention 1283| 4261| 1296| 4269