BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 4131739 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14195
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN THE FIELD REPRESENTATIVE INTERROGATED HE SECOND DEVICE (J177/103014) AFTER THE PROCEDURE WAS COMPLETE, IT SHOWED THAT NO TESTING WAS PERFORMED. THE DEVICE WAS PACING IN BOTH THE ATRIUM AND VENTRICLE WHICH CONFIRMS THAT THE DEVICE EXITED STORAGE MODE, BUT NO TESTING WAS PERFORMED. THE FIELD REPRESENTATIVE ALSO NOTED THERE WERE TWO PROGRAMMERS IN THE OPERATING ROOM WHICH COULD HAVE CAUSED SOME CONFUSION WITH INTERROGATION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) STATED ISSUES WERE LIKELY DUE TO EITHER THE DEVICE BEING PROGRAMMED IN UNIPOLAR MODE OR DEVICE NOT BEING INSERTED IN THE POCKET. THE PATIENT WAS CHECKED AND ALL MEASUREMENTS WERE APPROPRIATE AND THE RV IMPEDANCE MEASUREMENT HAD DECREASED TO 1,979 OHMS. IT WAS INDICATED THAT THE IMPLANTED DEVICE DATA WOULD BE SENT FOR REVIEW. TS INDICATED IF THE RV IMPEDANCE MEASUREMENT WAS ALWAYS GREATER THAN 2,000 OHMS, THE DEVICE WOULD NOT HAVE EXITED STORAGE MODE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE RIGHT VENTRICULAR (RV) LEAD (4474/437191) EXHIBITED HIGH THRESHOLD MEASUREMENTS. AS A RESULT, THE LEAD WAS REPOSITIONED BUT THE PHYSICIAN WAS NOT COMFORTABLE WITH THE HELIX MECHANISM. THEREFORE, THE LEAD WAS EXPLANTED AND DISCARDED. A NEW RV LEAD (7742/500548) WAS IMPLANTED. IMPEDANCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS, BUT ALL OTHER MEASUREMENTS WERE APPROPRIATE. THE LEADS WERE CONNECTED TO THE DEVICE (J177/105062); HOWEVER, THERE WERE NO ELECTROGRAMS (EGMS) AND TESTING COULD NOT BE PERFORMED. THE LEADS WERE DISCONNECTED AND RECONNECTED WITH THE SAME RESULTS. THE LEADS WERE TESTED THROUGH A PACING SYSTEM ANALYZER (PSA) WHICH NOTED THE SAME MEASUREMENTS THAT WERE PREVIOUSLY NOTED. THE LEADS WERE CONNECTED TO THE DEVICE AND AGAIN THE ISSUES PERSISTED. THE RIGHT ATRIAL (RA) LEAD WAS CONNECTED TO THE RV PORT AND THE DEVICE BEGAN TO OPERATE APPROPRIATELY. THE LEADS WERE THEN CONNECTED TO THEIR APPROPRIATE PORTS, EGMS WERE CLEAN AND TESTS WERE PERFORMED. DESPITE APPARENT NORMAL OPERATION, IT WAS DECIDED TO CHANGE THE DEVICE AS THERE WAS A SUSPECTED PROBLEM WITH THE DEVICE. A SECOND DEVICE (J177/103014) WAS IMPLANTED. WITH THIS NEW DEVICE, EGMS WERE SMALL AND THE TESTS AND OPERATION OBSERVED ON THE EGMS WERE CONFUSING AND DID NOT MATCH THE SURFACE EGM. THE RA LEAD WAS CONNECTED TO THE RV PORT BUT THERE WAS SOME CONFUSION WITH THE DEVICE OPERATION ON THE PROGRAMMER AND SURFACE ELECTROCARDIOGRAPHY. THE LEADS WERE THEN CONNECTED TO THE ORIGINAL DEVICE (J177/105062) AND TESTS NOTED APPROPRIATE RESULTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612654 INGENIO IMPLANTABLE PULSE GENERATOR LWS GUIDANT CRM CLONMEL IRELAND J177

    Patients

    Seq Age Sex Outcome Treatment
    1 7742| J177| 4480| 4474