BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2913142 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-16761
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 DURING A ROUTINE FOLLOW-UP APPOINTMENT, THE SHOCK IMPEDANCE MEASUREMENT ON THE RIGHT VENTRICULAR (RV) LEAD INCREASED TO GREATER THAN 200 OHMS. LEAD TESTING WAS PERFORMED AND A 41J SHOCK WAS DELIVERED. THE DEFIBRILLATION THRESHOLD (DFT) TEST WAS EFFECTIVE AND THE SHOCK IMPEDANCE MEASUREMENT WAS 70 OHMS. FOLLOWING THE TEST, THE IMPEDANCE MEASUREMENTS INCREASED TO GREATER THAN 200 OHMS. THE PHYSICIAN DECIDED TO LEAVE THE LEAD IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20466 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening 4554| 0181| P107| 4096