2026 data FDA MAUDE openFDA FDA Class III

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

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 Stimulator MID-BOOK · MAUDE

#65 of 1000 · 52,959 reports · 1999–2026

  • BOOK 52,959 reports
  • RANK #65 of 1000
  • DEATH 729 death-typed
  • INJ 25,355 injury-typed
  • MALF 26,645 malfunction
  • SPAN 1999–2026
  • PEAK 2018: 4,494
  • PHOTO Generator

Nearest event-volume peer: Generator, Oxygen, Portable (174 report gap)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor sits #65 of 1000 among tracked device types with 52,959 MAUDE reports spanning 1999–2026. 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

Stimulator carries 47.9% INJURY-coded reports, 17.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.1 pp)
  • INJ 47.9% corpus 30.3% · above corpus mean (+17.6 pp)
  • MALF 50.3% corpus 64.8% · below corpus mean (-14.5 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 19% of coded problems · Lead manufacturer MEDTRONIC PUERTO RICO OPERATIONS CO. accounts for 39% of manufacturer-tagged reports · Top event location is 47% of location-tagged rows .

Stimulator in the event-volume neighbourhood

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

reports

What this shows Stimulator, Electrical, Implanted, For Parkinsonian Tremor carries 52,959 MAUDE reports, ranked #65 of 1000.

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

Event Types

Malfunction 26,645 (50.3%)
Injury 25,355 (47.9%)
Death 729 (1.4%)
Other 193 (0.4%)
37 (0.1%)

Patient Outcomes

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

26,102 (46.5%)
Required Intervention 15,144 (27.0%)
Other 7,117 (12.7%)
Hospitalization 3,355 (6.0%)
R 2,091 (3.7%)
Death 726 (1.3%)
O 543 (1.0%)
H 283 (0.5%)
Life Threatening 247 (0.4%)
L 225 (0.4%)
Disability 130 (0.2%)
S 118 (0.2%)
D 17 (0.0%)
Congenital Anomaly 10 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 11,209
High impedance 7,291
Device Operates Differently Than Expected 5,009
Battery Problem 3,820
Failure to Deliver Energy 3,013
Connection Problem 2,889
Insufficient Device Problem Information 2,862
Low impedance 2,575
Charging Problem 2,542
Inappropriate/Inadequate Shock/Stimulation 2,421
Break 2,418
Material Integrity Problem 2,364
Communication or Transmission Problem 1,974
Device Displays Incorrect Message 1,467
Migration or Expulsion of Device 1,429
Premature Discharge of Battery 1,418
Electromagnetic Compatibility Problem 1,248
Impedance Problem 1,162
Unintended Collision 1,148
Malposition of Device 1,000

Yearly Trend

99
1999: 2
00
2000: 1
01
2001: 23
02
2002: 10
03
2003: 25
04
2004: 77
05
2005: 78
06
2006: 169
07
2007: 713
08
2008: 1,450
09
2009: 1,316
10
2010: 1,532
11
2011: 1,597
12
2012: 2,382
13
2013: 2,845
14
2014: 2,621
15
2015: 3,088
16
2016: 3,560
17
2017: 3,561
18
2018: 4,494
19
2019: 2,817
20
2020: 2,673
21
2021: 2,427
22
2022: 2,259
23
2023: 3,489
24
2024: 4,382
25
2025: 3,431
26
2026: 1,937

Reports in 2025 (3,431) held close to the prior two-year average of 3,936.

Related Entities for Stimulator, Electrical, Implanted, For Parkinsonian Tremor

Event Locations

25,001 (47.2%)
I 21,390 (40.4%)
OTHER 5,863 (11.1%)
UNKNOWN 473 (0.9%)
HOSPITAL 132 (0.2%)
NO INFORMATION 72 (0.1%)
HOME 25 (0.0%)
AMBULATORY SURGICAL FACILITY 2 (0.0%)
OUTDOORS 1 (0.0%)

Compare MEDTRONIC PUERTO RICO OPERATIONS CO. vs MEDTRONIC NEUROMODULATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for 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 (52,959 here).

Similar death-typed counts

Nearest other device types by death-typed report count (729 here), distinct from the volume row.

Disclaimer: MAUDE figures for 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 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.