Device, monitoring, intracranial pressure: medical device reports filed with FDA

6,858 reports carry this product code, 1992–2026; 13 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

6,858
reports with this product code: 0% of all MAUDE reports; 373
reports, 12 months to August 2026: 437 in the 12 months before; 70.9%
classified as malfunction: 62.3% across all reports; 1.2%
classified as death, as reported: 0.9% across all reports

Product code GWM is FDA's classification for "Device, monitoring, intracranial pressure" (neurology panel), a class 2 device. 6,858 medical device reports carry this product code, 0% of the MAUDE database, from April 1992 to August 2026.

373 reports arrived in the 12 months to August 2026, down 15% from 437 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (70.9%), injury (27.1%) and death (1.2%). 13 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Neuromonitor Basic Kit	754	18	0.4%	26.9%
Becker	257	18	0%	92.3%
Duet	255	10	0%	89.8%
Microsensor Ventricular Catheter Kit	225	2	1.3%	39.8%
Inter-Cranial Pressure And Temperature Monitor	215	0	0%	99.5%
EDM Lumbar Drainage Kit	209	54	0.5%	80.7%
Exacta	193	37	2%	90.8%
Olm Intracranial Pressure Monitoring Kit	180	0	5%	80.6%
Exacta External Drainage And Monitoring System	167	0	0%	97%
Cerelink Icp Probe Basic Kit	154	29	2.6%	33.1%
Codman	6	0	1.6%	57.9%
Strata	2	163	2.2%	53.6%
Unknown Catheter	1	26	2.2%	38.1%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Mexico	1,006	14.7%
Codman & Shurtleff	588	8.6%
Medtronic Neurosurgery	527	7.7%
Integra Lifesciences Mansfield	513	7.5%
Integra Lifesciences Switzerland Sar	455	6.6%
Integra Lifesciences Ireland	367	5.4%
Medtronic Mexico S De R L De Cv	363	5.3%
Codman & Shurtleff / Medos	251	3.7%
Raynham	203	3%
Codman & Shurtleff Medos	87	1.3%
Natus Medical	43	0.6%
Integra Lifesciences	6	0.1%
Codman And Shurtleff	4	0.1%
Integra Lifesciences Oh/USA	2	0%
Ge Oec Medical Systems	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.2%82

Injury27.1%1,857

Malfunction70.9%4,862

Other0.6%43

Not given0.2%14

Who filed

Manufacturer report97%6,652

Voluntary report1.1%74

User facility report0%0

Distributor report0%0

Not given1.9%132

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Fluid/blood leak	977	14.2%
Breakthe device broke	768	11.2%
Incorrect, inadequate or imprecise result or readings	562	8.2%
Disconnection	437	6.4%
Fracturea broken bone	393	5.7%
Device operates differently than expectedthe device behaved unexpectedly	304	4.4%
Device displays incorrect message	271	4%
Other (for use when an appropriate device code cannot be identified)	259	3.8%
Replace	256	3.7%
Unable to obtain readings	207	3%
Output problem	180	2.6%
Failure to zero	169	2.5%
False reading from device non-compliance	165	2.4%
Incorrect measurementthe device measured wrongly	164	2.4%
High readingsreadings were too high	153	2.2%
Low readingsreadings were too low	143	2.1%
Explanted	140	2%
Leak/splashthe device leaked	137	2%
No display/image	104	1.5%
Insufficient device problem information	94	1.4%

Questions about device, monitoring, intracranial pressure reports

What is product code GWM?

FDA's classification code for "Device, monitoring, intracranial pressure", class 2, reviewed by the neurology panel. Every device report carries the product code of the device involved.

How many reports carry this code?

6,858 reports through August 2026, 373 of them in the latest 12 months.

Which brands appear most often?

Neuromonitor Basic Kit (754), Becker (257), Duet (255), Microsensor Ventricular Catheter Kit (225) and Inter-Cranial Pressure And Temperature Monitor (215). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.