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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

3 linked reportsMalfunction 3
12232019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.25/device2019-05: 0 reports for this device; peer average 1.2/device2019-08: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.4/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 1.5/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.5/device2022-06: 0 reports for this device; peer average 1.67/device2022-07: 0 reports for this device; peer average 1.5/device2022-10: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-08: 1 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 1.33/device2024-07: 0 reports for this device; peer average 2.25/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 2.5/device2025-06: 1 reports for this device; peer average 1/device2025-08: 1 reports for this device; peer average 1.5/device010304050809101201070808010203060710010304050806070910030608
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0301
2019-0401.25
2019-0501.2
2019-0801.5
2019-0901.5
2019-1001.5
2019-1201
2020-0101.4
2020-0702
2020-0801
2021-0802
2022-0101.5
2022-0201
2022-0301.5
2022-0601.67
2022-0701.5
2022-1003
2023-0102
2023-0301
2023-0401
2023-0501
2023-0811.5
2024-0601.33
2024-0702.25
2024-0901
2024-1002
2025-0302.5
2025-0611
2025-0811.5
This device (reports/month)Average device in ETA, ETB (reports/device/month)
Failure-mode summaryAI-generated

3 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-08-181045254-2025-01993MalfunctionAvailablemodel number
2025-06-039612501-2025-01420MalfunctionAvailableexact di
2023-08-041045254-2023-00601MalfunctionAvailablemodel number
Regulatory clearances

    Predicate lineage

    K002897

    Cited as predicate by: K130512

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2024-06-17VAIVoluntary action indicatedMedtronic Xomed, Inc.1
    2021-10-29VAIVoluntary action indicatedMedtronic Xomed, Inc.5
    2015-09-21VAIVoluntary action indicatedMedtronic Xomed, Inc.1
    2012-07-03VAIVoluntary action indicatedMedtronic Xomed, Inc.8
    2012-06-06NAINo action indicatedMedtronic Xomed, Inc.0
    2010-08-05VAIVoluntary action indicatedMedtronic Xomed, Inc.4
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