BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2911819 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17094
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 30, 2012
    Report Date
    April 30, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    THE BOSTON SCIENTIFIC FIELD REPRESENTATIVE FOLLOWED UP WITH THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) WHO ALSO REPORTED THAT THIS PATIENT'S COMPETITOR'S RV TRANSVENOUS LEAD HAD EXHIBITED PACING IMPEDANCES OF < 200 OHMS; NO FURTHER INFORMATION WAS AVAILABLE RELATED TO THAT LEAD. THE HCP NOTED THE PATIENT WAS BEING REFERRED TO A SURGEON TO SEE IF HE WAS A CANDIDATE FOR EXTRACTION AS HE IS PACEMAKER DEPENDENT, HAS MULTIPLE HEALTH ISSUES AND IS ON CHRONIC ANTIBIOTIC THERAPY (NOT RELATED TO THE DEVICE). NO FURTHER INFORMATION WAS AVAILABLE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEFT-SIDED SYSTEM WAS ABANDONED DUE TO THE ISSUES WITH THE HIGH VOLTAGE PATCH AND LEADS, AS WELL AS, THE PATIENT HAD A CHRONIC POCKET INFECTION WHICH WAS BEING TREATED WITH INTRAVENOUS ANTIBIOTICS. THE DEVICE WAS PROGRAMMED TO VVI 30 AND A SINGLE LEAD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS IMPLANTED ON THE PATIENT'S RIGHT SIDE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD NOT BEEN EVALUATED FOR A PERIOD OF TIME, BUT RECENTLY THE PATIENT WAS SEEN FOR NORMAL FOLLOW-UP. AT THE CHECK, IT WAS NOTED THAT THERE WAS HIGH, OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCES ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND COMPETITOR'S RIGHT VENTRICULAR (RV) EPICARDIAL PATCH. DAILY MEASUREMENTS WITHIN THE DEVICE SHOW THAT SHOCK LEAD IMPEDANCES HAD BEEN VARIABLE BETWEEN 50 TO 125 OHMS FOR SOME TIME, BUT FOR THE LAST MONTH HAVE BEEN GREATER THAN 125 OHMS. ALSO NOTED WAS THE SHOCK ELECTROGRAM (EGM) WAS ALL NOISE AND NO CARDIAC ACTIVITY COULD BE SEEN ON IT. THE HEALTH CARE PROFESSIONAL (HCP) CONSULTED WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) AND A FRACTURE OF THE EPICARDIAL PATCH WAS SUSPECTED. IT WAS NOTED THE PATIENT WOULD NOT BE PROTECTED WITH THIS ISSUE AND THAT A TRUE TEST OF THE SYSTEM WOULD BE TO DELIVER A SHOCK TO GET AN IMPEDANCE MEASUREMENT. THE HCP WAS GOING TO DISCUSS THE FINDINGS WITH THE PHYSICIAN. AT THIS TIME, THE DEVICE AND PATCH REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17824 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4024| 4058| (B)(4)| 5076| N119| MISMATCH