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    MedTech Cybersecurity · Since 2022

    Goat Feed · MAUDE

    MAUDE adverse event: MicroPort CRM S.r.l. - HookUp

    Analysis synthesis:Review of the software analysis confirmed the reported behavior during the LBBOT procedure, with spontaneous QRS complexes incorrectly detected as pacing spikes, leading to inappropriate measurements.The investigation showed that a specific QRS morphology on le

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    MAUDE
    notablePublished October 5, 2026 at 2:11 PM UTC
    Blue Goat take· Blue Goat Cyber Research

    This software logic failure signifies that signal processing algorithms can misinterpret physiological data as device artifacts, causing clinical misdiagnosis without a hardware defect. Manufacturers of diagnostic cardiac software and pacing programmers are most exposed, especially those using automated spike detection. Teams should audit signal filtering thresholds for specific patient morphologies and monitor for similar algorithmic edge cases in field performance data.

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    • openFDA MAUDE
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    #maude#adverse-event#cyber
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