BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1945593 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-19951
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    GUIDANT CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 THRU Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS EVENT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRV RECEIVED INFORMATION THAT THIS DEVICE WAS UNABLE TO BE INTERROGATED. THE DEVICE DECLARED AND ELECTIVE REPLACEMENT INDICATOR (ERI) 5 MONTHS PRIOR. IT IS SUSPECTED THAT THIS BATTERY IS TO LOW TO PERFORM AN INTERROGATION. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CLONMEL IRELAND 1194

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 1194| (B)(4)