BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2913140 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16749
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 14, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER AND RIGHT VENTRICULAR LEAD DISPLAYED PAUSES IN PACING OF APPROXIMATELY 2.5 SECONDS. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT DEVICE MANIPULATION AND ISOMETRICS WERE UNABLE TO ANY NOISE OR REOCCURRENCE OF THE CLINICAL OBSERVATION. IMPEDANCE AND THRESHOLD MEASUREMENTS WERE ACCEPTABLE. THERE WAS NO FURTHER TROUBLE-SHOOTING PERFORMED AND THERE WAS NO PLAN FOR INTERVENTION AT THE TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19645 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1198

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR 1200| 4512| 1226| 4400| 1198