BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3043594 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02143
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 10, 2013
    Report Date
    October 11, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    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.

    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

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE SYSTEM DISPLAYED A SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS. THE PATIENT WAS BROUGHT INTO THE CLINIC. THE PHYSICIAN ORDERED A CHEST XRAY AND THE PATIENT WAS SENT HOME. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT DEVICE BASED TESTING WAS PERFORMED AND THE DEVICE SUCCESSFULLY CONVERTED AT 1.1J AND 41J WITH A SHOCK IMPEDANCE MEASUREMENT WITHIN ACCEPTABLE LIMITS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT NO INTERVENTION IS PLANNED AT THIS TIME AND THE PHYSICIAN WILL CONTINUE MONITORING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS CONTINUE TO BE OBSERVED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED POTENTIAL CAUSES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE CHEST X-RAY APPEARED UNREMARKABLE. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145199 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening 5076| 4087| 4549| MISMATCH| H217| 4592| N119