BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 3904140 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-07635
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    March 27, 2014
    Report Date
    September 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED THE RIGHT VENTRICULAR SEAL PLUG WAS SLICES, HOWEVER THE SEAL INTEGRITY WAS NOT COMPROMISED. ALL SETSCREWS MOVED FREELY AND IT WAS DETERMINED THE LEADS HAD BEEN FULLY INSERTED INTO THE DEVICE HEADER. THE DEVICE WAS RETURNED AT BEGINNING OF LIFE BATTERY STATUS IN SAFETY MODE THAT OCCURRED DUE TO AN UNKNOWN MEMORY FAULT. THE DEVICE SUCCESSFULLY RESET THE FAULT. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE 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. ANALYSIS CONCLUDED THERAPY WAS AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE EXPERIENCED A SYNCOPAL EPISODE AND WAS HOSPITALIZED. IT WAS NOTED, THERE HAD BEEN OVERSENSING RESULTING IN AN EIGHT SECOND ASYSTOLE EPISODE THAT OCCURRED WHILE THE PATIENT WAS IN THEIR HOME. INTERROGATION OF THIS DEVICE REVEALED A RED SCREEN THAT THE DEVICE WAS IN SAFETY CORE. AN EXTERNAL PACEMAKER WAS APPLIED UNTIL A REPLACEMENT PROCEDURE WAS PERFORMED. WHILE MONITORED IN THE HOSPITAL, A FURTHER EPISODE OF ASYSTOLE WAS OBSERVED. IT WAS THOUGHT THIS WAS DUE TO AFTER EFFECTS OF OVERSENSING. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED AND RECOMMENDED DEVICE REPLACEMENT. SUBSEQUENTLY, A REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. DURING THE PROCEDURE, VISUAL OBSERVATION DID NOT REVEAL ANY ASSOCIATED LEAD ISSUES. THE LEADS WERE RECONNECTED TO THE REPLACEMENT DEVICE.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382907 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND J173

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R J173| 4135| 4136