BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2162608 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07635
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 20, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    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 DURING A ROUTINE FOLLOW-UP VISIT, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE WITH OVERSENSING AND PACING INHIBITION. IT WAS NOTED THAT THE SENSING ON THE LEAD HAS BEEN DECREASING OVER THE LAST YEAR. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A LEAD REVISION PROCEDURE. THE RV LEAD WAS EXPLANTED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO INAPPROPRIATE THERAPY OCCURRED DUE TO THE NOISE. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE LEAD REVISION PROCEDURE. THE DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4456| 4469| 4518| 0185| 1298| N118