BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3050118 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-05499
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    October 1, 2012
    Report Date
    March 27, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    ADDITIONAL INFORMATION WAS RECEIVED THAT AN IN CLINIC EVALUATION WAS DONE AND THE SHOCK LEAD IMPEDANCE APPEARS STABLE WITH READINGS FROM 103-116 OHMS. IT WAS DISCUSSED THAT THE RV LEAD IS A SINGLE COIL LEAD SO CAN HAVE SHOCK LEAD IMPEDANCE MEASUREMENT IN THE 100 OHMS RANGE, BUT IT WOULD BE THE PHYSICIAN'S DISCRETION TO EVALUATE FURTHER OR TO MONITOR. AT THIS TIME, THE DECISION HAS BEEN MADE TO CONTINUE TO MONITOR. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS PATIENT'S HOME MONITORING SYSTEM DETECTED HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE HOME MONITORING INFORMATION AND IT APPEARS THAT THE SHOCK LEAD IMPEDANCE HAS BEEN VARIABLE, AND (B)(6) A READING OF 140 OHMS WAS DETECTED. AT THE BEGINNING OF THIS YEAR THE PATIENT WAS ENROLLED IN THE HOME REMOTE MONITORING SYSTEM THROUGH THE CLINIC, AND THE RECENT ALERT WAS SUBSEQUENTLY DETECTED AND TRANSMITTED. EVALUATION OPTIONS WERE DISCUSSED WITH THE PATIENT'S HEALTH CARE PROFESSIONAL (HCP) AND THE FIELD REPRESENTATIVE. THE PATIENT WAS GOING TO BE SEEN IN CLINIC FOR EVALUATION. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT SHOW FOR THE FOLLOW-UP APPOINTMENT, AND WAS CONTACTED AND RESCHEDULED FOR THE NEAR FUTURE.

    Description of Event or Problem · 1

    SUBSEQUENT HIGH, OUT OF RANGE, SHOCK LEAD IMPEDANCE WAS AGAIN TRANSMITTED THROUGH THE REMOTE MONITORING SYSTEM. IT WAS REPORTED THAT HE PATIENT WAS RECENTLY SEEN IN CLINIC, AND NOTHING HAD CHANGED RELATED TO IMPEDANCE; THE HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE EVALUATION WAS NORMAL. MONITORING WILL CONTINUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148881 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR N119| 0180| MISMATCH| 4591| 4542