BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3053292 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05455
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    July 3, 2014
    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 CURRENTLY AVAILABLE 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 THIS PATIENT'S HOME MONITORING SYSTEM TRANSMITTED INFORMATION THAT HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCES FOR THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WERE DETECTED. TRENDING DATA WAS REVIEWED AND THE SHOCK LEAD IMPEDANCES FOR THIS LEAD WERE GRADUALLY INCREASING SINCE (B)(6), AND NOW OOR MEASUREMENTS WERE OBTAINED. IN CLINIC TESTING WAS PERFORMED AND NO NOISE WAS OBSERVED OR REPRODUCED, AND ALL OTHER LEAD MEASUREMENTS WERE NORMAL; HOWEVER, THE SHOCK LEAD IMPEDANCES WERE OOR IN ALL AVAILABLE SHOCKING CONFIGURATIONS. IN LAB TESTING OF THE SYSTEM WITH SYNCHRONIZED LOW AND HIGH VOLTAGE SHOCKS WAS ANTICIPATED TO BE DONE IN THE NEXT MONTH. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE SHOCK LEAD IMPEDANCE CONTINUED TO RISE, THEREFORE, THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE RIGHT VENTRICULAR (RV) LEAD, THE CRT-D GENERATOR REMAINS IN SERVICE. A FRACTURE AT THE PROXIMAL END OF THE DISTAL COIL WAS SUSPECTED, AS INITIALLY THE STYLET WAS ABLE TO BE PASSED DOWN, BUT THEN WHEN THE HELIX WAS UNABLE TO BE RETRACTED, AND THERE APPEARED TO BE SOME ISSUES. HOWEVER, IT WAS NOTED THERE WAS NO VISIBLE FRACTURE IDENTIFIED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS SYSTEM WAS EVALUATED IN THE LAB. A 41 JOULE SHOCK WAS DELIVERED IN THE TRIAD CONFIGURATION AND THE IMPEDANCE WAS 96 OHMS. PRIOR TO SHOCK DELIVERY TRIAD MEASUREMENT WAS AROUND 120 OHMS, COIL TO COIL WAS 150 OHMS, AND COIL TO CAN WAS 160 OHMS. AFTER SHOCK DELIVERY TRIAD PAINLESS MEASUREMENT WAS 109 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE DELIVERED SHOCK IMPEDANCE WAS HIGH FOR TRIAD, BUT NOT A SURPRISE GIVEN THAT IT HAD BEEN RISING, AND THE REASON FOR THE RISE WAS UNCLEAR. IT WAS NOTED THAT MONITORING WOULD NEED TO CONTINUE, AND INDICATORS TO WATCH FOR THAT MAY INDICATE FURTHER SHOCKS ARE NEEDED TO TEST THE INTEGRITY OF THE SYSTEM WERE REVIEWED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155540 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R 4087| 4543| 0185| N119| H210