BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2171581 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09992
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WITH THIS PACEMAKER, SENT IN A PATIENT VERIFICATION FORM TO BOSTON SCIENTIFIC WITH A HANDWRITTEN NOTE ON IT. THE NOTE STATES THAT THIS DEVICE IS NO LONGER WORKING AND HASN'T BEEN FOR ALMOST 2 YEARS, DUE TO A BAD LEAD CONNECTION. THE PATIENT ONLY HAS ONE LEAD AND THAT IS A NON BOSTON SCIENTIFIC LEAD. 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 CRM CLONMEL IRELAND 1198

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR 1198| 8416| (B)(4)