2026 data FDA MAUDE openFDA

Implanted Subcortical Electrical Stimulator (Motor Disorders)

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 MAUDE casebook

openFDA event book Implanted Subcortical Electrical Stimulator LIGHT-BOOK · MAUDE

#417 of 1000 · 2,909 reports · 2001–2026

  • BOOK 2,909 reports
  • RANK #417 of 1000
  • DEATH 16 death-typed
  • INJ 1,329 injury-typed
  • MALF 1,563 malfunction
  • SPAN 2001–2026
  • PEAK 2023: 306
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Spinous Process Spacer/Plate (1 report gap)

Implanted Subcortical Electrical Stimulator (Motor Disorders) sits #417 of 1000 among tracked device types with 2,909 MAUDE reports spanning 2001–2026. 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

Implanted Subcortical Electrical Stimulator carries 45.7% INJURY-coded reports, 15.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 45.7% corpus 30.3% · above corpus mean (+15.4 pp)
  • MALF 53.7% corpus 64.8% · below corpus mean (-11.1 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 15% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 49% of manufacturer-tagged reports · Top event location is 61% of location-tagged rows .

Implanted Subcortical Electrical Stimulator in the event-volume neighbourhood

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

reports

What this shows Implanted Subcortical Electrical Stimulator (Motor Disorders) carries 2,909 MAUDE reports, ranked #417 of 1000.

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

Event Types

Malfunction 1,563 (53.7%)
Injury 1,329 (45.7%)
Death 16 (0.6%)
1 (0.0%)

Patient Outcomes

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

1,558 (50.5%)
Required Intervention 1,019 (33.0%)
Hospitalization 160 (5.2%)
R 126 (4.1%)
Other 119 (3.9%)
L 23 (0.7%)
Life Threatening 21 (0.7%)
O 19 (0.6%)
Death 17 (0.6%)
S 9 (0.3%)
H 6 (0.2%)
Disability 6 (0.2%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 623
High impedance 399
Battery Problem 314
Failure to Deliver Energy 293
Charging Problem 279
Device Operates Differently Than Expected 274
Connection Problem 266
Material Integrity Problem 230
Communication or Transmission Problem 183
Break 175
Insufficient Device Problem Information 167
Low impedance 154
Migration or Expulsion of Device 147
Inappropriate/Inadequate Shock/Stimulation 125
Malposition of Device 110
Device Displays Incorrect Message 103
Impedance Problem 99
Improper or Incorrect Procedure or Method 93
Electromagnetic Compatibility Problem 88
Low Battery 81

Yearly Trend

01
2001: 1
08
2008: 1
12
2012: 33
13
2013: 247
14
2014: 247
15
2015: 302
16
2016: 299
17
2017: 163
18
2018: 61
19
2019: 198
20
2020: 133
21
2021: 143
22
2022: 167
23
2023: 306
24
2024: 267
25
2025: 218
26
2026: 123

Reports in 2025 (218) held close to the prior two-year average of 287.

Related Entities for Implanted Subcortical Electrical Stimulator (Motor Disorders)

Event Locations

1,766 (60.7%)
I 1,133 (38.9%)
NO INFORMATION 6 (0.2%)
HOME 1 (0.0%)
HOSPITAL 1 (0.0%)
OTHER 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MEDTRONIC MED REL MEDTRONIC PUERTO RICO →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Implanted Subcortical Electrical Stimulator: 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 (2,909 here).

Similar death-typed counts

Nearest other device types by death-typed report count (16 here), distinct from the volume row.

Disclaimer: MAUDE figures for Implanted Subcortical Electrical Stimulator 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 Implanted Subcortical Electrical Stimulator; 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.