Devices › Device, monitoring, intracranial pressure
Device brand name · Neuro monitoring
Olm Intracranial Pressure Monitoring Kit: medical device reports filed with FDA
180 reports name it, 1998–2023. Manufacturer given most often on reports: Integra Neurosciences Ca/USA. Product code GWM.
- 180
- device reports naming the brand
- 0% of all MAUDE reports · about 6 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 80.6%
- classified as malfunction
- 70.9% across the product code
- 5%
- classified as death, as reported
- 9 reports · not verified by FDA
180 medical device reports received by FDA name the brand "Olm Intracranial Pressure Monitoring Kit" (neuro monitoring); the manufacturer given most often on reports is Integra Neurosciences Ca/USA; received from January 1998 to November 2023. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (80.6%), injury (12.8%) and death (5%); across all device, monitoring, intracranial pressure reports (product code GWM) death is recorded in 1.2% and malfunction in 70.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device operates differently than expected (12.8%), break (5%) and device displays incorrect message (5%). The patient problems coded most often are death, brain injury and loss of consciousness. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 6,858 reports carrying product code GWM. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 23 | 12.8% | 4.4% |
| Breakthe device broke | 9 | 5% | 11.2% |
| Device displays incorrect message | 9 | 5% | 4% |
| False reading from device non-compliance | 9 | 5% | 2.4% |
| High readingsreadings were too high | 9 | 5% | 2.2% |
| Unable to obtain readings | 9 | 5% | 3% |
| Bent | 6 | 3.3% | 0.4% |
| Device inoperablethe device could not be used | 6 | 3.3% | 0.9% |
| Device slipped | 6 | 3.3% | 0.2% |
| Improper device output | 6 | 3.3% | 0.5% |
| Failure to zero | 4 | 2.2% | 2.5% |
| No display/image | 4 | 2.2% | 1.5% |
| Component missing | 3 | 1.7% | 0.1% |
| Improper or incorrect procedure or method | 3 | 1.7% | 0.5% |
| Low readingsreadings were too low | 3 | 1.7% | 2.1% |
| Decrease in pressure | 2 | 1.1% | 0.1% |
| Defective component | 2 | 1.1% | 0.4% |
| Detachment of device component | 2 | 1.1% | 0.5% |
| Erratic or intermittent display | 2 | 1.1% | 0.2% |
| Incorrect, inadequate or imprecise result or readings | 2 | 1.1% | 8.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 7 | 3.9% |
| Brain injury | 2 | 1.1% |
| Loss of consciousnesspassing out | 2 | 1.1% |
| No patient involvement | 2 | 1.1% |
| Cardiac arrestthe heart stopped | 1 | 0.6% |
| Complaint, ill-defined | 1 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.6% |
| Overdosea dose above the recommended amount | 1 | 0.6% |
| Painpain, site not specified | 1 | 0.6% |
| Pulmonary embolisma blood clot in the lung | 1 | 0.6% |
| Tissue damage | 1 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Olm Intracranial Pressure Monitoring Kit | Product code GWM | All MAUDE reports |
|---|---|---|---|
| Reports | 180 | 6,858 | 26,136,888 |
| Share of that pool | — | 2.6% | 0% |
| Classified as death, per 1,000 reports | 50 | 12 | 9 |
| Classified as injury | 12.8% | 27.1% | 36.2% |
| Classified as malfunction | 80.6% | 70.9% | 62.3% |
| Filed by the manufacturer | 98.9% | 97% | 94.9% |
Shares are of reports, not of devices in use. 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."
Other brands with product code GWM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Neuromonitor Basic Kit | 757 | 18 | 0.4% |
| Becker | 261 | 18 | 0% |
| Duet | 265 | 10 | 0% |
| Microsensor Ventricular Catheter Kit | 231 | 2 | 1.3% |
| Inter-Cranial Pressure And Temperature Monitor | 217 | 0 | 0% |
| EDM Lumbar Drainage Kit | 218 | 54 | 0.5% |
| Exacta | 196 | 37 | 2% |
| Exacta External Drainage And Monitoring System | 167 | 0 | 0% |
| Cerelink Icp Probe Basic Kit | 154 | 29 | 2.6% |
| Codman | 183 | 0 | 1.6% |
| Strata | 817 | 163 | 2.2% |
| Unknown Catheter | 270 | 26 | 2.2% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Olm Intracranial Pressure Monitoring Kit reports
How many FDA reports name Olm Intracranial Pressure Monitoring Kit?
180 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (80.6%), injury (12.8%) and death (5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device operates differently than expected (12.8%), break (5%), device displays incorrect message (5%), false reading from device non-compliance (5%) and high readings (5%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Olm Intracranial Pressure Monitoring Kit was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.