BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1952291 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23981
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, INITIAL INTERROGATION WAS UNSUCCESSFUL. NORMAL INTERROGATION WAS OBSERVED AFTER CONFIRMING INITIAL TELEMETRY PROBLEMS. A REVIEW OF THE DEVICE MEMORY NOTED MULTIPLE RESETS HAD OCCURRED. THE DEVICE PASSED ALL MANUAL ELECTRICAL MEASUREMENTS AND PACED AND SENSED NORMALLY DURING TESTING. X-RAY ANALYSIS CONFIRMED NO IRREGULARITIES. UPON FURTHER TESTING THE OUT OF RANGE TELEMETRY NOISE POP UP WINDOW WOULD FLASH ON THE PROGRAMMER. MANIPULATING THE PACEMAKER CASING WOULD CAUSE THE DEVICE TO GO THROUGH RESETS AND PACING WOULD STOP. THE PACEMAKER WAS SUBJECTED TO THOROUGH TESTING, AT WHICH TIME THE PACEMAKER CASE WAS OPENED AND AGAIN, SEVERAL RESETS HAD OCCURRED. THE CAUSE OF THE MISSING DAILY MEASUREMENTS WAS DUE TO AN INTERMITTENT OPEN IN ONE OF THE CIRCUITS WHICH WOULD CAUSE THE DEVICE TO ISSUE A SYSTEM RESET WHICH THEN CLEARED THE DAILY MEASUREMENT LOG.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER WAS RETURNED FOR DISPOSAL. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE, AND THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1