BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2055870 · Received April 14, 2011

    Report

    Report Number
    2124215-2011-04643
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    December 21, 2005
    Report Date
    March 15, 2011
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICAL SERVICES CONSULTANT PERFORMED A LONGEVITY CALCULATION AND ENGINEERING DEPARTMENT REVIEWED HEX DUMP RESULTS. IT WAS DETERMINED THAT THE DEVICE WAS OPERATING NORMALLY. THE TECHNICAL SERVICES CONSULTANT SUSPECTED THAT A REPORTED VARIANCE IN IMPEDANCE THE DAY OF THE VISIT, CAUSED THE SHIFT IN LONGEVITY. THE CLINICIAN PLANNED TO MONITOR THE PATIENT MONTHLY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WIL L BE REOPENED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER HAD 1.5 YEARS REMAINING, WITH A MAGNET RATE OF 100BPM AT THE BEGINNING OF A FOLLOW-UP VISIT. AFTER DEVICE TESTING, A READING OF <.5 YEARS REMAINING APPEARED AND THE BATTERY STATUS WAS ELECTICE REPLACEMENT NEAR (ERN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1298

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR MISMATCH| 1298