BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2913736 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00058
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 24, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    ADDITIONAL INFORMATION HAS BECOME AVAILABLE THAT THIS DEVICE WAS EXPLANTED AT THE SAME TIME THE NON BSC RV LEAD WAS REMOVED. AT THE TIME OF THE LEAD REVISION, IT WAS DETERMINED THAT THIS PATIENT NO LONGER NEEDS AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE PHYSICIAN ELECTED TO IMPLANT A SINGLE CHAMBER DEVICE AS NEEDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A HIGH OUT OF RANGE PACING IMPEDANCE FOR THIS PATIENT'S NON BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS SEEN IN CLINIC WHERE LOSS OF CAPTURE (LOC) AND PACING INHIBITION AND OVERSENSING WAS NOTED. THE DEVICE ALSO DELIVERED ANTI-TACHYCARDIA PACING (ATP) ON ONE OCCASION. THE PHYSICIAN STATED THAT THEY PLAN TO REVISE THE LEAD SOON. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19693 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| L| R 6949| 4542| MISMATCH| 4543| 1270| 4469| N119| A155