BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2781028 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13203
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    July 22, 2010
    Report Date
    September 28, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE THRESHOLD TESTING DATE CONFLICT COULD NOT BE CONFIRMED. DURING ROUTINE TESTING, THE DEVICE DID NOT PASS THE ANALYSIS LONGEVITY TEST. THE DEVICE CASE WAS OPENED TO DETERMINE THE CAUSE OF THE HIGH CURRENT DRAIN. DURING DETAILED TESTING, THE DEVICE ELECTRICALLY FUNCTIONED NORMALLY. THE CAUSE OF THE UNEXPECTED DEPLETION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED FOR NORMAL BATTERY DEPLETION (NBD). PREVIOUSLY A CONFLICTING THRESHOLD MEASUREMENT DATE WAS REPORTED. THE DEVICE WAS NOTED TO BE FUNCTIONING NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1296

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4086| 4087| 1296