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    MedTech Cybersecurity · Since 2022

    Goat Feed · MAUDE

    MAUDE adverse event: Medtronic, Inc. - Medtronic IPG

    It was reported by the patient that they received a letter from Medtronic indicating that there was a personal data breach. The Impl antable Pulse Generator (IPG) remains in use. No patient complications have been reported as a result of this event. Correction: B5 Medtronic subm

    Back to the daily feed
    MAUDE
    notablePublished October 5, 2026 at 2:11 PM UTC
    Blue Goat take· Blue Goat Cyber Research

    This MAUDE entry signals that data privacy incidents now trigger mandatory medical device reporting if the breach involves information linked to active implants. Manufacturers of Class III life sustaining devices are most exposed here, as even non-clinical IT breaches now require regulatory filings under 21 CFR 803. The FDA will likely increase scrutiny on how backend data security impacts overall device system integrity.

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    • openFDA MAUDE
    • Methodology and sources →
    #maude#adverse-event#cyber
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