BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2173842 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-11822
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 8, 2018
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT LOOKED AT THE TRENDING DATA AND SUGGESTED TALKING TO THIS PATIENT'S PHYSICIAN TO DETERMINE IF THE BONE STIMULATOR CAN BE TURNED OFF TO SEE IF SHOCKING LEAD IMPEDANCE MEASUREMENTS NORMALIZE. THE CONSULTANT DISCUSSED THIS TEST IS HIGHLY SENSITIVE TO ELECTROMAGNETIC INTERFERENCE (EMI). HOWEVER, THEY CANNOT RULE OUT A SHORTED SHOCKING LEAD AND IF THE MEASUREMENTS DO NOT NORMALIZE, FURTHER TESTING WILL BE REQUIRED FOR PATIENT SAFETY. THE CONSULTANT REVIEWED THE DEVICE DATA AND NOTED THE LAST CAPACITOR REFORMATION WAS ON (B)(6) 2011. IT WAS ALSO NOTED THAT WHEN A REAL SHOCK WAS DELIVERED, IT WAS OKAY WITH NORMAL IMPEDANCE MEASUREMENTS OBSERVED. NOISE WAS NOTED ON ALL THREE CHANNELS. HOWEVER, NO OVERSENSING WAS OBSERVED EXCEPT DURING THE LUMBAR SURGERY ON (B)(6) 2011. THE CONSULTANT SUGGESTED REVIEWING THE NEXT CAPACITOR REFORMATION AND TO CONSIDER PERFORMING AN INDUCTION TO PROVE THERE IS NO INTERACTION WITH DEFIBRILLATION TESTING (DFT). THE CALLER WILL DISCUSS THE ISSUES FURTHER WITH THIS PATIENT'S PHYSICIAN. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-VALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUBSEQUENTLY EXPLANTED FOR A SEPARATE ISSUE. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, 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 HAD UNDERGONE LUMBAR SURGERY AND IS USING A BONE STIMULATOR WHICH IS CAUSING RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD IMPEDANCES TO DECREASE. A RED ALERT WAS DISPLAYED FOR SHOCKING IMPEDANCE LESS THAN 20 OHMS AND NOISE WAS OBSERVED. THE PATIENT PERFORMED ANOTHER PATIENT INITIATED INTERROGATION (PII) WITH THE BONE GROWTH STIMULATOR TURNED OFF AND SHOCKING IMPEDANCE WAS NORMAL AT 45 OHMS. THE PATIENT IS IMMOBILIZED AND CANNOT COME INTO THE OFFICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR N119| 4555| 0185| 4470