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

#414 of 1000 · 2,832 reports · 2001–2026

  • BOOK 2,832 reports
  • RANK #414 of 1000
  • DEATH 16 death-typed
  • INJ 1,296 injury-typed
  • MALF 1,519 malfunction
  • SPAN 2001–2026
  • PEAK 2023: 306
  • PHOTO Culture Media

Nearest event-volume peer: Culture Media, Enriched (7 report gap)

Implanted Subcortical Electrical Stimulator (Motor Disorders) sits #414 of 1000 among tracked device types with 2,832 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 0.6% corpus 1.5% · below corpus mean (-1.0 pp)
  • INJ 45.8% corpus 30.4% · above corpus mean (+15.3 pp)
  • MALF 53.6% corpus 64.5% · below corpus mean (-10.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 13% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 49% of manufacturer-tagged reports · Top event location is 60% 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 2,832 MAUDE reports, ranked #414 of 1000.

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

Event Types

Malfunction 1,519 (53.6%)
Injury 1,296 (45.8%)
Death 16 (0.6%)
1 (0.0%)

Patient Outcomes

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

1,508 (50.1%)
Required Intervention 995 (33.1%)
Hospitalization 159 (5.3%)
R 126 (4.2%)
Other 117 (3.9%)
L 23 (0.8%)
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 382
Battery Problem 277
High impedance 258
Connection Problem 252
Charging Problem 241
Material Integrity Problem 224
Failure to Deliver Energy 209
Insufficient Information 149
Communication or Transmission Problem 142
Break 114
Device Operates Differently Than Expected 114
Low impedance 104
Migration or Expulsion of Device 98
Improper or Incorrect Procedure or Method 86
Malposition of Device 83
Inappropriate/Inadequate Shock/Stimulation 79
Impedance Problem 78
Delayed Charge Time 58
Electromagnetic Compatibility Problem 55
Premature Discharge of Battery 53

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: 169
23
2023: 306
24
2024: 266
25
2025: 222
26
2026: 41

Related Entities for Implanted Subcortical Electrical Stimulator (Motor Disorders)

Event Locations

1,689 (59.6%)
I 1,133 (40.0%)
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 similar MAUDE profiles

Two openFDA-derived peer sets for Implanted Subcortical Electrical Stimulator, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,832 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.