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.
24 linked reportsMalfunction 14Injury 8Death 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 6 | 57.33 |
| 2019-02 | 3 | 71.33 |
| 2019-03 | 0 | 82.5 |
| 2019-04 | 0 | 72 |
| 2019-05 | 1 | 44.33 |
| 2019-06 | 2 | 41 |
| 2019-07 | 0 | 62.5 |
| 2019-08 | 1 | 44.33 |
| 2019-09 | 0 | 56 |
| 2019-10 | 1 | 43 |
| 2019-11 | 1 | 54.33 |
| 2019-12 | 2 | 35 |
| 2020-01 | 0 | 50 |
| 2020-02 | 0 | 64 |
| 2020-03 | 0 | 60 |
| 2020-04 | 0 | 23.5 |
| 2020-05 | 1 | 21 |
| 2020-06 | 0 | 44 |
| 2020-07 | 1 | 27.33 |
| 2020-08 | 1 | 33 |
| 2020-09 | 1 | 26.67 |
| 2020-10 | 0 | 53 |
| 2020-11 | 0 | 44.5 |
| 2020-12 | 0 | 48 |
| 2021-01 | 0 | 58 |
| 2021-02 | 0 | 42.5 |
| 2021-03 | 0 | 40 |
| 2021-04 | 0 | 45 |
| 2021-05 | 1 | 22.67 |
| 2021-06 | 0 | 39 |
| 2021-07 | 0 | 38.5 |
| 2021-08 | 0 | 30.5 |
| 2021-09 | 1 | 20.67 |
| 2021-10 | 0 | 21.33 |
| 2021-11 | 0 | 19 |
| 2021-12 | 0 | 17.67 |
| 2022-01 | 0 | 13.67 |
| 2022-02 | 0 | 22.33 |
| 2022-03 | 0 | 23.67 |
| 2022-04 | 0 | 21.67 |
| 2022-05 | 0 | 13 |
| 2022-06 | 0 | 17 |
| 2022-07 | 0 | 16.67 |
| 2022-08 | 0 | 13.33 |
| 2022-09 | 0 | 18.33 |
| 2022-10 | 0 | 14 |
| 2022-11 | 0 | 29.5 |
| 2022-12 | 0 | 15 |
| 2023-01 | 0 | 14 |
| 2023-02 | 0 | 26 |
| 2023-03 | 0 | 25.67 |
| 2023-04 | 0 | 28.5 |
| 2023-05 | 0 | 18.75 |
| 2023-06 | 0 | 12.75 |
| 2023-07 | 0 | 13.25 |
| 2023-08 | 0 | 15.2 |
| 2023-09 | 0 | 20.75 |
| 2023-10 | 0 | 23.5 |
| 2023-11 | 0 | 13.67 |
| 2023-12 | 1 | 11.8 |
| 2024-01 | 0 | 12.8 |
| 2024-02 | 0 | 14.6 |
| 2024-03 | 0 | 13.33 |
| 2024-04 | 0 | 12.33 |
| 2024-05 | 0 | 13 |
| 2024-06 | 0 | 13.4 |
| 2024-07 | 0 | 11.2 |
| 2024-08 | 0 | 15 |
| 2024-09 | 0 | 15.6 |
| 2024-10 | 0 | 16.8 |
| 2024-11 | 0 | 16.6 |
| 2024-12 | 0 | 11.33 |
| 2025-01 | 0 | 17.4 |
| 2025-02 | 0 | 12.8 |
| 2025-03 | 0 | 15.33 |
| 2025-04 | 0 | 9.8 |
| 2025-05 | 0 | 16.4 |
| 2025-06 | 0 | 16.2 |
| 2025-07 | 0 | 23.6 |
| 2025-08 | 0 | 16.2 |
| 2025-09 | 0 | 8.83 |
| 2025-10 | 0 | 13.2 |
| 2025-11 | 0 | 19.67 |
| 2025-12 | 0 | 20.8 |
| 2026-01 | 0 | 21.6 |
| 2026-02 | 0 | 21.8 |
| 2026-03 | 0 | 22 |
| 2026-04 | 0 | 27.4 |
| 2026-05 | 0 | 24.8 |
| 2026-06 | 0 | 29.5 |
Failure-mode summaryAI-generated
24 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-12-11 | 2017865-2023-94488 | Death | Available | exact di |
| 2021-09-17 | 2017865-2021-30691 | Malfunction | Available | exact di |
| 2021-05-27 | 2017865-2021-19676 | Malfunction | Available | exact di |
| 2020-09-25 | 2017865-2020-14256 | Malfunction | Available | exact di |
| 2020-08-16 | 2017865-2020-11479 | Injury | Available | exact di |
| 2020-07-28 | 2017865-2020-09985 | Malfunction | Available | exact di |
| 2020-05-28 | 2017865-2020-06730 | Death | Available | exact di |
| 2019-12-20 | 2017865-2019-18233 | Injury | Available | exact di |
| 2019-12-19 | 2017865-2019-18234 | Injury | Available | exact di |
| 2019-11-11 | 2017865-2019-16238 | Malfunction | Available | exact di |
| 2019-10-23 | 2017865-2019-15458 | Malfunction | Available | exact di |
| 2019-08-19 | 2017865-2019-12535 | Malfunction | Available | exact di |
| 2019-06-19 | 2017865-2019-09829 | Malfunction | Available | exact di |
| 2019-06-07 | 2017865-2019-09109 | Injury | Available | exact di |
| 2019-05-24 | 2017865-2019-08532 | Injury | Available | exact di |
Showing the most recent 18 of 24 linked reports.
Showing 1–15 of 18
Regulatory clearances
- 510(k)K122161Substantially equivalent (SESE) · 2012-11-28clearance family
- 510(k)K122090Substantially equivalent (SESE) · 2012-11-15clearance family
Predicate lineage
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
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-08-13 | NAI | No action indicated | St. Jude Medical | 0 |
| 2019-03-20 | NAI | No action indicated | St. Jude Medical | 0 |
| 2018-03-20 | NAI | No action indicated | St. Jude Medical | 0 |
| 2016-07-28 | VAI | Voluntary action indicated | St. Jude Medical | 9 |
| 2016-04-11 | NAI | No action indicated | St. Jude Medical | 0 |
| 2015-09-30 | WL | Warning Letter | St. Jude Medical | — |
| 2015-06-26 | OAI | Official action indicated | St. Jude Medical | 12 |
| 2014-07-31 | NAI | No action indicated | St. Jude Medical | 0 |
| 2014-05-06 | NAI | No action indicated | St Jude Medical Inc | 0 |
| 2012-10-03 | NAI | No action indicated | St Jude Medical Inc | 0 |
| 2012-06-05 | WL | Warning Letter | St. Jude Medical | — |
| 2012-02-28 | NAI | No action indicated | St. Jude Medical | 0 |
| 2011-11-30 | OAI | Official action indicated | St. Jude Medical | 3 |
| 2011-06-15 | OAI | Official action indicated | St. Jude Medical | 0 |
| 2011-04-21 | VAI | Voluntary action indicated | St. Jude Medical | 0 |
| 2011-03-21 | NAI | No action indicated | St. Jude Medical | 0 |
| 2011-03-01 | NAI | No action indicated | St. Jude Medical | 0 |
| 2010-09-21 | VAI | Voluntary action indicated | St Jude Medical Inc | 0 |
| 2010-04-19 | NAI | No action indicated | St. Jude Medical | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | St Jude Medical Inc | 5 |
| 2010-01-22 | VAI | Voluntary action indicated | St. Jude Medical | 5 |
| 2009-04-17 | WL | Warning Letter | St. Jude Medical | — |
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