BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3043127 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01381
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    March 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION,PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Additional Manufacturer Narrative · 1

    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 DURING AN IMPLANT PROCEDURE THIS DEVICE WAS CONNECTED TO THE EXISTING RIGHT VENTRICULAR (RV) LEAD. THE VENTRICULAR LEAD EXHIBITED HIGH PACING IMPEDANCES GREATER THAN 2,000 OHMS. THE DEVICE WAS DISCONNECTED FROM THE LEAD AND REINSERTED INTO THE LEAD MULTIPLE TIMES TO CHECK FOR A CONNECTION ISSUES. HIGH PACING IMPEDANCES CONTINUED TO OCCUR DURING DEVICE TESTING. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER DEVICE. A NEW DEVICE WAS CONNECTED WITH THE EXISTING LEADS;TESTED AND ALL ISSUES WERE RESOLVED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS RETURNED FOR ANALYSIS .

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145643 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J172

    Patients

    Seq Age Sex Outcome Treatment
    1