2026 data FDA MAUDE openFDA FDA Class II

Device, Monitoring, Intracranial Pressure

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 §882.1620 (Neurology panel).

FDA MAUDE casebook

openFDA event book Device, Monitoring, Intracranial Pressure LIGHT-BOOK · MAUDE

#271 of 1000 · 6,841 reports · 1992–2026

  • BOOK 6,841 reports
  • RANK #271 of 1000
  • DEATH 82 death-typed
  • INJ 1,853 injury-typed
  • MALF 4,849 malfunction
  • SPAN 1992–2026
  • PEAK 2023: 744
  • PHOTO Pad, Heating, Powered

Nearest event-volume peer: Pad, Heating, Powered (37 report gap)

Device, Monitoring, Intracranial Pressure sits #271 of 1000 among tracked device types with 6,841 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 →

Malfunction reports run above the device-type norm

Device, Monitoring, Intracranial Pressure carries 70.9% MALFUNCTION-coded reports, 6.1pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.2% corpus 1.5% · near corpus mean (-0.3 pp)
  • INJ 27.1% corpus 30.3% · below corpus mean (-3.2 pp)
  • MALF 70.9% corpus 64.8% · above corpus mean (+6.1 pp)

Lead product-problem code Fluid/Blood Leak is 16% of coded problems · Lead manufacturer MEDTRONIC MEXICO accounts for 53% of manufacturer-tagged reports · Top event location is 65% of location-tagged rows .

Device, Monitoring, Intracranial Pressure in the event-volume neighbourhood

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

reports

What this shows Device, Monitoring, Intracranial Pressure carries 6,841 MAUDE reports, ranked #271 of 1000.

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

Event Types

Malfunction 4,849 (70.9%)
Injury 1,853 (27.1%)
Death 82 (1.2%)
Other 43 (0.6%)
14 (0.2%)

Patient Outcomes

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

4,778 (68.7%)
Required Intervention 1,396 (20.1%)
Other 439 (6.3%)
R 106 (1.5%)
Hospitalization 92 (1.3%)
Death 82 (1.2%)
H 17 (0.2%)
O 17 (0.2%)
Life Threatening 12 (0.2%)
L 7 (0.1%)
Disability 5 (0.1%)
S 3 (0.0%)
D 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 980
Break 766
Incorrect, Inadequate or Imprecise Result or Readings 566
Disconnection 444
Fracture 393
Device Operates Differently Than Expected 307
Device Displays Incorrect Message 275
Other (for use when an appropriate device code cannot be identified) 262
Replace 257
Unable to Obtain Readings 209
Output Problem 181
Failure to Zero 172
Incorrect Measurement 166
False Reading From Device Non-Compliance 165
High Readings 158
Low Readings 149
Explanted 141
Leak/Splash 141
Appropriate Device Problem Term/Code Not Available 137
No Display/Image 107

Yearly Trend

92
1992: 4
93
1993: 1
94
1994: 1
95
1995: 2
96
1996: 10
97
1997: 30
98
1998: 55
99
1999: 44
00
2000: 25
01
2001: 37
02
2002: 78
03
2003: 129
04
2004: 149
05
2005: 86
06
2006: 97
07
2007: 126
08
2008: 105
09
2009: 117
10
2010: 104
11
2011: 184
12
2012: 151
13
2013: 120
14
2014: 360
15
2015: 486
16
2016: 419
17
2017: 445
18
2018: 302
19
2019: 260
20
2020: 268
21
2021: 211
22
2022: 424
23
2023: 744
24
2024: 641
25
2025: 446
26
2026: 180

Reports fell to 446 in 2025, down from an average of 693 in the two years before.

Related Entities for Device, Monitoring, Intracranial Pressure

Event Locations

4,475 (65.4%)
I 2,136 (31.2%)
HOSPITAL 165 (2.4%)
NO INFORMATION 46 (0.7%)
INVALID DATA 18 (0.3%)
OTHER 1 (0.0%)

Compare MEDTRONIC MEXICO vs MEDTRONIC NEUROSURGERY →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Device, Monitoring, Intracranial Pressure: 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 (6,841 here).

Similar death-typed counts

Nearest other device types by death-typed report count (82 here), distinct from the volume row.

Disclaimer: MAUDE figures for Device, Monitoring, Intracranial Pressure 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 Device, Monitoring, Intracranial Pressure; 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.