BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1771532 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12816
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    October 9, 2009
    Report Date
    June 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH DEVICE EVALUATION WAS PERFORMED. THE DEVICE AT INCOMING, DISPLAYED IN MEMORY EVIDENCE THAT THE ADDRESS WAS CORRUPTED. THIS VALUE WAS CLEARED DURING TESTING. EXPOSURE TO RADIATION IS BELIEVED TO HAVE SET THE MEMORY LOCATION TO AN INCORRECT STATE. THE DEVICE WAS PUT THROUGH AND PASSED A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIED THE PERFORMANCE OF PACING, SENSING, AND RECORDING FUNCTIONS OF THE DEVICE COMMENSURATE WITH BATTERY VOLTAGE. ADDITIONAL TESTING WAS PERFORMED TO ADDRESS THE OBSERVED HIGH RATE PACING IN THE CLINICAL SETTING. RATE RESPONSE (XL) WAS PROGRAMMED ON, THE DEVICE WAS THEN SHAKEN AND THE PACING RATE INCREASED WHICH IS AS EXPECTED FOR HAVE THE XL ON. THE DEVICE THEN RETURNED TO A NORMAL PACING RATE AT REST. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PACEMAKER DEPENDENT PATIENT WAS RECEIVING RADIATION TREATMENT FOR PROSTATE CANCER. THE PATIENT CAME INTO THE CLINIC AFTER A TREATMENT AND PACING AT THE MAXIMUM SENSOR RATE (MSR) OF 130PPM WAS OBSERVED. THE CLINICIAN TURNED OFF RATE RESPONSE AND PACING RESUMED AT THE LOWER RATE LIMIT (LRL). HOWEVER, WHEN RATE RESPONSE WAS TURNED BACK ON, MSR PACING BEGAN WITHIN A COUPLE OF MINUTES. THE PACEMAKER WAS EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT.

    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 MISMATCH| 4456| 1291