BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2951033 · Received February 8, 2013

    Report

    Report Number
    2124215-2013-02778
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    February 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED, THE MAGNET WAS NOT ACTUALLY PLACED DIRECTLY ON THE PATIENT'S CHEST SINCE THE AREA WAS IN THE STERILE FIELD OF THE OPERATING ROON. THE DEVICE WAS CHECKED FOLLOWING THE PROCEDURE AND FOUND TO BE IN WORKING ORDER WITH NO ISSUES OBSERVED. THERE WAS PACING INHIBITION NOTED BUT WAS A RESULT FROM THE CAUTERY BEING USED DURING THE PROCEDURE. NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD UNDERGONE OPEN HEART SURGERY. DURING THE PROCEDURE IT WAS REPORTED THE DEVICE DID NOT PACE WHEN A MAGNET WAS PLACED. THE LOCAL FIELD REPRESENTATIVE WAS GOING TO BE PAGED FOR ASSISTANCE. A REQUEST FOR ADDITIONAL INFORMATION HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54577 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1190

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 1170| 1190| 1488T