BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGNIA

    MDR report key: 1952845 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24509
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 5, 2010
    Report Date
    December 5, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A HEALTH CARE PROVIDER CALLED BOSTON SCIENTIFIC TECHNICAL SERVICE (TS) ASKING TO PERFORM A TRANS TELEPHONIC MONITORING (TTM) INTERROGATION AS THIS PATIENT EXPERIENCED A SYNCOPAL EVENT. THE TS CONSULTANT STATED THAT THEY CAN NOT DO THAT, BUT A SALES REPRESENTATIVE CAN BE PAGED TO COME OUT AND PERFORM AND INTERROGATION. ATTEMPTS TO GAIN ADDITIONAL INFORMATION REGARDING ANY SUBSEQUENT INTERROGATION HAVE BEEN UNSUCCESSFUL. 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 1290

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other 4136| 4135| 1290