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2026 data FDA MAUDE openFDA FDA Class II

Generator, Lesion, Radiofrequency

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §882.4400 (Neurology panel).

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FDA MAUDE casebook

openFDA event book Generator, Lesion, Radiofrequency LIGHT-BOOK · MAUDE

#521 of 1000 · 1,812 reports · 1992–2026

  • BOOK 1,812 reports
  • RANK #521 of 1000
  • DEATH 5 death-typed
  • INJ 758 injury-typed
  • MALF 976 malfunction
  • SPAN 1992–2026
  • PEAK 2019: 195
  • PHOTO Stimulator

Nearest event-volume peer: Stimulator, Electrical, Implanted, For Parkinsonian Symptoms (2 report gap)

Generator, Lesion, Radiofrequency sits #521 of 1000 among tracked device types with 1,812 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports run above the device-type norm

Generator, Lesion, Radiofrequency carries 41.8% INJURY-coded reports, 11.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 41.8% corpus 30.3% · above corpus mean (+11.5 pp)
  • MALF 53.9% corpus 64.8% · below corpus mean (-11.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 14% of coded problems · Lead manufacturer ST. JUDE MEDICAL, INC. accounts for 45% of manufacturer-tagged reports · Top event location is 50% of location-tagged rows .

Generator, Lesion, Radiofrequency in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Generator, Lesion, Radiofrequency carries 1,812 MAUDE reports, ranked #521 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 976 (53.9%)
Injury 758 (41.8%)
Other 61 (3.4%)
12 (0.7%)
Death 5 (0.3%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

967 (53.0%)
Other 698 (38.3%)
Required Intervention 100 (5.5%)
Hospitalization 21 (1.2%)
R 13 (0.7%)
Life Threatening 11 (0.6%)
L 4 (0.2%)
Death 4 (0.2%)
O 3 (0.2%)
Disability 3 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 214
Temperature Problem 140
Device Operates Differently Than Expected 137
Insufficient Heating 137
Device Displays Incorrect Message 106
Output Problem 86
Fracture 79
Insufficient Device Problem Information 75
Self-Activation or Keying 68
Communication or Transmission Problem 67
Failure to Power Up 53
Thermal Decomposition of Device 45
Smoking 44
Unknown (for use when the device problem is not known) 44
High impedance 37
Unexpected Shutdown 35
Impedance Problem 30
Overheating of Device 29
Connection Problem 28
Device Inoperable 27

Yearly Trend

92
1992: 2
94
1994: 1
95
1995: 6
96
1996: 6
97
1997: 10
98
1998: 7
99
1999: 3
00
2000: 11
01
2001: 4
02
2002: 13
03
2003: 6
04
2004: 44
05
2005: 76
06
2006: 7
07
2007: 10
08
2008: 10
09
2009: 12
10
2010: 69
11
2011: 89
12
2012: 77
13
2013: 119
14
2014: 64
15
2015: 67
16
2016: 51
17
2017: 83
18
2018: 156
19
2019: 195
20
2020: 138
21
2021: 154
22
2022: 84
23
2023: 54
24
2024: 63
25
2025: 88
26
2026: 33

Reports rose to 88 in 2025, up from an average of 59 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Generator, Lesion, Radiofrequency

Top Manufacturers

ST. JUDE MEDICAL, INC. 393
STRYKER INSTRUMENTS KALAMAZOO 146
STRYKER INSTRUMENTS-KALAMAZOO 145
ST. JUDE MEDICAL 113
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 86

Event Locations

908 (50.1%)
I 795 (43.9%)
HOSPITAL 73 (4.0%)
OUTPATIENT TREATMENT FACILITY 12 (0.7%)
NO INFORMATION 8 (0.4%)
AMBULATORY SURGICAL FACILITY 4 (0.2%)
INVALID DATA 4 (0.2%)
OTHER 4 (0.2%)
UNKNOWN 3 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)

Compare ST. JUDE MEDICAL, INC. vs STRYKER INSTRUMENTS KALAMAZOO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Generator, Lesion, Radiofrequency: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,812 here).

Stimulator 1,810 Over-The-Counter Automated External Defibri… 1,803 Operating Room Accessories Table Tray 1,802 Needle, Aspiration And Injection, Disposable 1,796

Similar death-typed counts

Nearest other device types by death-typed report count (5 here), distinct from the volume row.

Anesthesia Conduction Kit 5 Antigens, All Groups, Streptococcus Spp. 5 Apparatus, Exhaust, Surgical 5 Bit, Drill 5

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Generator, Lesion, Radiofrequency are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Generator, Lesion, Radiofrequency; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.