BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2040874 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00877
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 WHILE THIS PACEMAKER DEPENDENT PATIENT WAS IN THE HOSPITAL FOR AN UNRELATED ISSUE, NOISE ON THE RIGHT VENTRICULAR (RV) CHANNEL AND APPROXIMATELY SIX SECONDS OF PACING INHIBITION WERE OBSERVED ON THE ELECTROGRAM. THE PHYSICIAN SUSPECTED A LEAD TO DEVICE HEADER CONNECTION ISSUE, SO THE PATIENT WAS SCHEDULED FOR A REVISION PROCEDURE. UPON OPENING THE POCKET, THE PHYSICIAN WAS ABLE TO RECREATE THE NOISE AND PACING INHIBITION BY PUSHING ON THE RV LEAD. SUBSEQUENTLY, THE RV LEAD WAS TAKEN OUT OF AND REINSERTED INTO THE DEVICE HEADER, THE SEAL PLUG WAS BURPED AND NO OTHER ISSUES WERE OBSERVED. IT WAS NOTED THAT THERE HAD BEEN NO OUT OF RANGE IMPEDANCE MEASUREMENTS ON THE RV LEAD AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Hospitalization| L| R 4088| 0185| 4470| 4136| N119| 4592| 4555| 1296| 4543