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SEEQ™

Model SEEQ14 · MEDTRONIC, INC. · DI 00643169513648

DSI — Detector And Alarm, Arrhythmia · Class II · 21 CFR 870.1025

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

122335472019-01: 0 reports for this device; peer average 29.54/device2019-02: 0 reports for this device; peer average 26.62/device2019-03: 0 reports for this device; peer average 46.6/device2019-04: 0 reports for this device; peer average 36.6/device2019-05: 0 reports for this device; peer average 27.92/device2019-06: 0 reports for this device; peer average 24.23/device2019-07: 0 reports for this device; peer average 35.58/device2019-08: 0 reports for this device; peer average 23.54/device2019-09: 0 reports for this device; peer average 37.18/device2019-10: 0 reports for this device; peer average 31.45/device2019-11: 0 reports for this device; peer average 36.5/device2019-12: 0 reports for this device; peer average 30.36/device2020-01: 0 reports for this device; peer average 33.2/device2020-02: 0 reports for this device; peer average 36.5/device2020-03: 0 reports for this device; peer average 30.92/device2020-04: 0 reports for this device; peer average 17.64/device2020-05: 0 reports for this device; peer average 17.38/device2020-06: 0 reports for this device; peer average 21.31/device2020-07: 0 reports for this device; peer average 22.29/device2020-08: 0 reports for this device; peer average 23.92/device2020-09: 0 reports for this device; peer average 20.64/device2020-10: 0 reports for this device; peer average 24.83/device2020-11: 0 reports for this device; peer average 29.46/device2020-12: 0 reports for this device; peer average 17.53/device2021-01: 0 reports for this device; peer average 12/device2021-02: 0 reports for this device; peer average 19.93/device2021-03: 0 reports for this device; peer average 22.62/device2021-04: 0 reports for this device; peer average 25.63/device2021-05: 0 reports for this device; peer average 16.4/device2021-06: 0 reports for this device; peer average 18.06/device2021-07: 0 reports for this device; peer average 13.76/device2021-08: 0 reports for this device; peer average 12.94/device2021-09: 0 reports for this device; peer average 22.47/device2021-10: 0 reports for this device; peer average 9.41/device2021-11: 0 reports for this device; peer average 13.93/device2021-12: 0 reports for this device; peer average 11.22/device2022-01: 0 reports for this device; peer average 17.93/device2022-02: 0 reports for this device; peer average 13/device2022-03: 0 reports for this device; peer average 12.65/device2022-04: 0 reports for this device; peer average 18.07/device2022-05: 0 reports for this device; peer average 12.93/device2022-06: 0 reports for this device; peer average 11.5/device2022-07: 0 reports for this device; peer average 9.47/device2022-08: 0 reports for this device; peer average 14.15/device2022-09: 0 reports for this device; peer average 15/device2022-10: 0 reports for this device; peer average 27.44/device2022-11: 0 reports for this device; peer average 12.19/device2022-12: 0 reports for this device; peer average 14.57/device2023-01: 0 reports for this device; peer average 12.25/device2023-02: 0 reports for this device; peer average 15.25/device2023-03: 0 reports for this device; peer average 19.33/device2023-04: 0 reports for this device; peer average 10.44/device2023-05: 0 reports for this device; peer average 18.07/device2023-06: 0 reports for this device; peer average 13.91/device2023-07: 0 reports for this device; peer average 14.71/device2023-08: 0 reports for this device; peer average 18.16/device2023-09: 0 reports for this device; peer average 12.93/device2023-10: 0 reports for this device; peer average 12.94/device2023-11: 0 reports for this device; peer average 17.92/device2023-12: 0 reports for this device; peer average 10.5/device2024-01: 0 reports for this device; peer average 16.75/device2024-02: 0 reports for this device; peer average 13.86/device2024-03: 0 reports for this device; peer average 12.38/device2024-04: 0 reports for this device; peer average 11.71/device2024-05: 0 reports for this device; peer average 20.27/device2024-06: 0 reports for this device; peer average 15.5/device2024-07: 0 reports for this device; peer average 10.15/device2024-08: 0 reports for this device; peer average 12.55/device2024-09: 0 reports for this device; peer average 11.48/device2024-10: 0 reports for this device; peer average 22.24/device2024-11: 0 reports for this device; peer average 13.13/device2024-12: 0 reports for this device; peer average 9/device2025-01: 0 reports for this device; peer average 16.05/device2025-02: 0 reports for this device; peer average 10.83/device2025-03: 0 reports for this device; peer average 15.8/device2025-04: 0 reports for this device; peer average 7.92/device2025-05: 0 reports for this device; peer average 15.64/device2025-06: 0 reports for this device; peer average 12.73/device2025-07: 0 reports for this device; peer average 15.76/device2025-08: 0 reports for this device; peer average 18.08/device2025-09: 0 reports for this device; peer average 8.5/device2025-10: 0 reports for this device; peer average 13.95/device2025-11: 0 reports for this device; peer average 14.96/device2025-12: 0 reports for this device; peer average 13.38/device2026-01: 0 reports for this device; peer average 14.95/device2026-02: 0 reports for this device; peer average 11.67/device2026-03: 0 reports for this device; peer average 17.35/device2026-04: 0 reports for this device; peer average 20.43/device2026-05: 0 reports for this device; peer average 14.89/device2026-06: 0 reports for this device; peer average 16.74/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01029.54
2019-02026.62
2019-03046.6
2019-04036.6
2019-05027.92
2019-06024.23
2019-07035.58
2019-08023.54
2019-09037.18
2019-10031.45
2019-11036.5
2019-12030.36
2020-01033.2
2020-02036.5
2020-03030.92
2020-04017.64
2020-05017.38
2020-06021.31
2020-07022.29
2020-08023.92
2020-09020.64
2020-10024.83
2020-11029.46
2020-12017.53
2021-01012
2021-02019.93
2021-03022.62
2021-04025.63
2021-05016.4
2021-06018.06
2021-07013.76
2021-08012.94
2021-09022.47
2021-1009.41
2021-11013.93
2021-12011.22
2022-01017.93
2022-02013
2022-03012.65
2022-04018.07
2022-05012.93
2022-06011.5
2022-0709.47
2022-08014.15
2022-09015
2022-10027.44
2022-11012.19
2022-12014.57
2023-01012.25
2023-02015.25
2023-03019.33
2023-04010.44
2023-05018.07
2023-06013.91
2023-07014.71
2023-08018.16
2023-09012.93
2023-10012.94
2023-11017.92
2023-12010.5
2024-01016.75
2024-02013.86
2024-03012.38
2024-04011.71
2024-05020.27
2024-06015.5
2024-07010.15
2024-08012.55
2024-09011.48
2024-10022.24
2024-11013.13
2024-1209
2025-01016.05
2025-02010.83
2025-03015.8
2025-0407.92
2025-05015.64
2025-06012.73
2025-07015.76
2025-08018.08
2025-0908.5
2025-10013.95
2025-11014.96
2025-12013.38
2026-01014.95
2026-02011.67
2026-03017.35
2026-04020.43
2026-05014.89
2026-06016.74
This device (reports/month)Average device in DSI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K133701 — cites (transitively): K113372 (d1) — cited as predicate by K153160, K162956, K163512, K190939, K231620

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — MEDTRONIC, INC.

  • Warning Letter 2021-12-09 Medtronic MiniMed, Inc.
  • Warning Letter 2018-08-23 Medtronic Puerto Rico Operations Co.
  • Warning Letter 2018-07-30 Medtronic, Inc.
  • Warning Letter 2018-07-30 Medtronic, Inc.
  • Injunction 2015-04-29 Medtronic Neuromodulation
  • Warning Letter 2014-06-02 Heartware, Inc.
  • Warning Letter 2013-09-19 Medtronic MiniMed, Inc.
  • Warning Letter 2012-07-17 Medtronic Neuromodulation
  • Warning Letter 2010-05-07 Medtronic Navigation, Inc.
  • Warning Letter 2009-11-09 Medtronic, Inc.
  • NAI 2026-05-27 SPR Therapeutics Inc. · 0 citations
  • NAI 2026-02-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2025-12-15 MEDTRONIC GRAND RAPIDS · 2 citations
  • VAI 2025-11-11 Scientia Vascular, Inc. · 1 citations
  • NAI 2025-03-14 Medtronic Puerto Rico Operations Co. · 0 citations
  • VAI 2025-02-10 Medtronic, Inc. · 1 citations
  • VAI 2025-02-10 Medtronic, Inc. · 1 citations
  • NAI 2024-12-05 Medtronic Powered Surgical Solutions · 0 citations
  • VAI 2024-10-31 Medtronic CryoCath LP · 1 citations
  • NAI 2024-08-09 Medtronic, Inc. · 0 citations
  • NAI 2024-08-09 Medtronic, Inc. · 0 citations
  • VAI 2024-06-17 Medtronic Xomed, Inc. · 1 citations
  • VAI 2024-06-11 Medtronic Navigation, Inc.-Boxborough · 2 citations
  • VAI 2024-02-09 Medtronic Navigation, Inc. · 3 citations
  • NAI 2024-02-01 MEDTRONIC CARE MANAGEMENT SERVICES · 0 citations
  • NAI 2024-01-03 Medtronic MiniMed, Inc. · 0 citations
  • NAI 2023-09-01 Medtronic, Inc. · 0 citations
  • NAI 2023-09-01 Medtronic, Inc. · 0 citations
  • VAI 2023-05-05 Medtronic Neuromodulation · 4 citations
  • VAI 2023-03-10 Medtronic MiniMed, Inc. · 3 citations