BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3212544 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10064
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 29, 2013
    Report Date
    September 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, PIN GAUGE TESTING VERIFIED THAT THE RIGHT VENTRICULAR (RV) LEAD RING LEAF SPRING WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT LEAD REVISION WAS PERFORMED. THE DEVICE WAS ELECTIVELY EXPLANTED DURING THE LEAD REVISION. A NEW DEVICE WAS IMPLANTED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE LEADS REMAIN IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD THAT RESULTED IN PACING TO BE INHIBITED WITH ASYSTOLE. OVERSENSING WAS ALSO PRESENT HOWEVER, THERE WAS NO INAPPROPRIATE THERAPY. PATIENT NOTED BEING IN ATRIAL FIBRILLATION (AF) AND IS ESSENTIALLY PACER DEPENDENT. A VENOGRAM WAS GOING TO BE PERFORMED. TACHY THERAPY WAS TURNED OFF UNTIL LEAD REVISION PERFORMED. PATIENT HAS LIFE VEST. A REQUEST FOR LEAD STATUS HAS BEEN SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313121 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R H135| 4469| H215| N118| 4512| 0158