BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2040122 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-00519
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 4, 2012
    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 AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE DEVICE UNDERWENT FUNCTIONAL TESTING. WHILE UNDERGOING TESTING THE DEVICE SENSED AND RESPONDED APPROPRIATELY TO APPLIED STIMULI. THIS DEVICE MET SPECIFICATION.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY ADDITIONAL INFORMATION WAS RECIEVED STATING THAT THIS DEVICE WAS TAKEN OUT OF SERVICE FOR NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS REPORTED FROM THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEVICE WAS OVERSENSING RESULTING IN ASYSTOLE. THIS ONLY OCCURRED DURING INTRINSIC BEATS. THRESHOLDS WERE REPORTED AS NORMAL. BOSTON SCIENTIFIC TECHNICAL SERVICES WAS CONTACTED WHOM RECOMMENDED PROGRAMMING CHANGES WHICH WERE IMPLEMENTED. CURRENTLY THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. 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 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR (B)(4)| (B)(4)| (B)(4)| 1290