BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 3040787 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00853
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    March 13, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION IDENTIFIED THE PRESENCE OF WHAT APPEARED TO BE AN ELECTROCAUTERY MARK ON THE DEVICE CASE. INTERROGATION CONFIRMED THE DEVICE WAS OPERATING IN SAFETY MODE. DEVICE MEMORY WAS EXTRACTED AND REVIEW FOUND THAT THREE LEAD LEAKAGE FAULTS AND ONE POWER-ON-RESET (POR) HAD BEEN RECORDED ON THE DATE OF ATTEMPTED IMPLANT. ADDITIONALLY, MEMORY CORRUPTION WAS NOTED. DUE TO THE MEMORY CORRUPTION, THE DEVICE COULD NOT BE PROGRAMMED OUT OF SAFETY MODE. DEVICE FIRMWARE WAS RELOADED AND; SUBSEQUENTLY, THE DEVICE COULD BE SUCCESSFULLY INTERROGATED AND COMMUNICATED WITH. THE DEVICE WAS PROGRAMMED TO DDD AND ELECTRICAL TESTS VERIFIED NORMAL OPERATION. NEXT, THE DEVICE CASE WAS REMOVED TO FACILITATE ANALYSIS OF INTERNAL COMPONENTS. HIGH POWERED VISUAL INSPECTION IDENTIFIED NO ANOMALIES. ALL POWER SUPPLY MEASUREMENTS WERE WITHIN EXPECTED RANGES. THE CURRENT DRAIN WAS MONITORED FOR 12 DAYS AND REMAINED WITHIN EXPECTED RANGES DURING THAT TIME. THE DEVICE HYBRID WAS REMOVED AND INDIVIDUALLY TESTED. NO PRODUCT PERFORMANCE ISSUES WERE NOTED. DESPITE DETAILED ANALYSIS, THE CAUSE OF THE IDENTIFIED MEMORY CORRUPTION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS PACEMAKER, INITIAL INTERROGATION WITH A PROGRAMMER REVEALED NO ANOMALIES. AFTER CONNECTING THE LEADS TO THE DEVICE HEADER, RF TELEMETRY BETWEEN THE DEVICE AND PROGRAMMER WAS LOST. THE PROGRAMMER WAND WAS PLACED OVER THE DEVICE AT WHICH TIME, FAULT CODES WERE OBSERVED AND THE DEVICE WAS FOUND TO BE IN SAFETY CORE. THE DEVICE WAS SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143389 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR S402| 4554| 4135| 4136| K063