BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2911327 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15958
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 5, 2012
    Report Date
    November 28, 2012
    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

    ALL AVAILABLE INFORMATION INDICATES THE 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 THIS PACEMAKER TRIPPED ELECTIVE REPLACEMENT INDICATOR (ERI) RECENTLY. THE DEVICE HAD AN ESTIMATED LONGEVITY OF ONE YEAR FIVE MONTHS EARLIER. AUTOMATIC CAPTURE WAS PROGRAMMED ON. THERE WAS A CONCERN THAT THE INCREASED OUTPUT AS A RESULT OF THE DEVICE GOING INTO RETRY WOULD HAVE CAUSED THE DEVICE TO DECLARE ERI EARLIER THAN EXPECTED. A DEVICE REPLACEMENT IS PLANNED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18259 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 4469| 4470| 1290