BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2911453 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16221
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 20, 2012
    Report Date
    May 24, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT FOR THE NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR (RV) LEAD. AN EMAIL WAS SENT TO THE FIELD REPRESENTATIVE IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION RELATING TO THE REASON FOR THE OUT OF RANGE MEASUREMENT AND RESOLUTION TO THE EVENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT ANOTHER ALERT WAS GENERATED BY THE REMOTE HOME MONITORING SYSTEM FOR A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT ON THE NON-BOSTON SCIENTIFIC LEAD. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED AND YIELDED NORMAL SHOCK IMPEDANCE MEASUREMENTS.THE PHYSICIAN IS CONSIDERING A REVISION PROCEDURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND ANOTHER MANUFACTURER'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED ADDITIONAL HIGH OUT OF RANGE SHOCKING LEAD IMPEDANCE MEASUREMENTS OF GREATER THAN 200 OHMS. CONTINUOUS SHOCK IMPEDENCE TESTING SHOWED OUT OF RANGE MEASUREMENTS. A REPEAT ECHO WAS PERFORMED WHICH INDICATED AN EJECTION FRACTION OF 50 PERCENT. THUS THE PATIENT AND PHYSICIAN ELECTED TO TURN OFF TACHYCARDIA THERAPY TO PREVENT ANY FUTURE INAPPROPRIATE SHOCKS DUE TO ANY SHOCK LEAD ISSUES. AT THIS TIME THE DEVICE AND RV LEAD REMAIN IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17737 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 4591| H170| 4537| 4086| 6932| N119| MISMATCH