BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2173773 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11256
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPECTED FOR EXPLANT IN THE NEAR FUTURE. THE BSC SALES REPRESENTATIVE DID NOT THINK THE DEVICE WOULD BE RETURNED BY THE HOSPITAL, AS THE DEVICE WAS PLANNED FOR CHANGEOUT TO A NON-BSC DEVICE. NO FURTHER INFORMATION IS EXPECTED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC (BSC) RECEIVED INFORMATION THAT THIS PULSE GENERATOR DID REACH END OF LIFE AND WAS SUSPECTED FOR PREMATURE DEPLETION FOR IT HAD ONLY BEEN IMPLANTED FOR ABOUT THREE YEARS. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) THRESHOLDS HAD BEEN PROGRAMMED HIGH AND THE REASON FOR THAT WAS NOT KNOWN AT THE TIME OF THIS INITIAL REPORT. THE BSC SALES REPRESENTATIVE DID NOT THINK THE PATIENT WAS PACEMAKER DEPENDENT AND ALSO DID NOTE THAT RV PACING WAS AT 99%. THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THESE CLINICAL OBSERVATIONS.

    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 74 YR 4470| 1291| 4469