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NIM-Response®
Model 8253001 · MEDTRONIC XOMED, INC. · DI 00643169230385
ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820
GWF — Stimulator, Electrical, Evoked Response · Class II · 21 CFR 882.1870
UDILibrary device dossier · generated 2026-09-15 · 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 (304)
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.
Malfunction: 280 · Injury: 24
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
10
3.07
2019-02
10
3.8
2019-03
5
3.09
2019-04
2
1.86
2019-05
2
2.02
2019-06
1
1.57
2019-07
2
1.72
2019-08
2
4.08
2019-09
4
2.77
2019-10
10
4.26
2019-11
11
4.47
2019-12
8
4.76
2020-01
3
3.33
2020-02
2
2.1
2020-03
0
3.9
2020-04
0
2.54
2020-05
0
1.55
2020-06
0
1.69
2020-07
0
2.68
2020-08
2
2.92
2020-09
4
2.89
2020-10
2
4.06
2020-11
2
2.7
2020-12
5
2.89
2021-01
0
1.16
2021-02
0
2.22
2021-03
2
1.84
2021-04
1
1.97
2021-05
2
1.66
2021-06
1
2.28
2021-07
0
3.11
2021-08
1
2.31
2021-09
2
4
2021-10
0
2.62
2021-11
0
2
2021-12
1
1.59
2022-01
0
2.18
2022-02
0
1.95
2022-03
0
1.46
2022-04
0
2.44
2022-05
2
2.77
2022-06
0
2.17
2022-07
2
1.77
2022-08
2
2.15
2022-09
0
2.12
2022-10
3
2.46
2022-11
0
2.18
2022-12
2
2.03
2023-01
0
2.73
2023-02
3
2.11
2023-03
1
2.27
2023-04
2
1.65
2023-05
2
2.35
2023-06
0
2.05
2023-07
1
1.75
2023-08
5
2.89
2023-09
0
3.44
2023-10
6
6.93
2023-11
11
6
2023-12
4
7.44
2024-01
2
5.07
2024-02
9
6.33
2024-03
4
6.35
2024-04
8
8.98
2024-05
7
8.71
2024-06
4
6.63
2024-07
6
10.31
2024-08
5
12.34
2024-09
9
17.49
2024-10
9
14.17
2024-11
4
12.6
2024-12
9
9.08
2025-01
1
8.76
2025-02
8
14.62
2025-03
18
13.68
2025-04
4
10.84
2025-05
2
8.45
2025-06
8
9.62
2025-07
1
16.34
2025-08
3
9.21
2025-09
6
10.32
2025-10
1
15.2
2025-11
5
13.17
2025-12
8
12.27
2026-01
3
9.72
2026-02
3
9.3
2026-03
6
11.82
2026-04
2
11.74
2026-05
3
12.65
2026-06
3
13.23
This device (reports/month)Average device in ETN, GWF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K083124 — cited as predicate by K111647, K142624, K162199, K162313, K181559, K182542, K200759, K223254, K233001, K251672
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — MEDTRONIC XOMED, INC.
VAI 2024-06-17 Medtronic Xomed, Inc. · 1 citations
VAI 2021-10-29 Medtronic Xomed, Inc. · 5 citations
VAI 2015-09-21 Medtronic Xomed, Inc. · 1 citations
VAI 2012-07-03 Medtronic Xomed, Inc. · 8 citations
NAI 2012-06-06 Medtronic Xomed, Inc. · 0 citations
VAI 2010-08-05 Medtronic Xomed, Inc. · 4 citations