BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3040667 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00438
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2012
    Report Date
    January 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    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 THE PATIENT WITH THIS DEVICE SYSTEM REPORTED SYMPTOMS OF FATIGUE, SECONDARY TO BRADYCARDIA WITH PREMATURE VENTRICULAR CONTRACTIONS AND HYPOTENSION. THE PATIENT ALSO EXPERIENCED A HEART RATE IN THE 40 BPM RANGE DESPITE THE DEVICE BEING PROGRAMMED TO PACING AT 65 BPM. THE PATIENT'S CARDIOLOGIST ELECTED TO DISCONTINUE A PRESCRIPTION DRUG. NO FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143849 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 4472| H175| 0184| 4542| N119| MISMATCH| 4473| 4517| 4524| N118