BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 1951444 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22878
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    October 20, 2010
    Report Date
    November 25, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Removal / Correction Number
    Z-0187-06 TO Z-0190-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LAST MONTH THIS BATTERY STATUS WAS AT 90BPM, AND DURING THE MOST RECENT TRANSTELEPHONIC MEASURING INTERROGATION, THE BATTERY STATUS WAS AT 100BPM. TO DATE, THERE HAVE BEEN NO ADDITIONAL 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 1194

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR (B)(4)| (B)(4)| (B)(4)