Devices › Device, monitoring, intracranial pressure
Device brand name · Device monitoring intracranial pressure
EDM Lumbar Drainage Kit: medical device reports filed with FDA
218 reports name it, 2012–2026. Manufacturer given most often on reports: Medtronic Mexico S De R L De Cv. Product code GWM.
- 218
- device reports naming the brand
- 0% of all MAUDE reports · about 16 a year
- 54
- reports, 12 months to August 2026
- 45 in the 12 months before
- 80.7%
- classified as malfunction
- 70.9% across the product code
- 0.5%
- classified as death, as reported
- 1 reports · not verified by FDA
218 medical device reports received by FDA name the brand "EDM Lumbar Drainage Kit" (device monitoring intracranial pressure); the manufacturer given most often on reports is Medtronic Mexico S De R L De Cv; received from October 2012 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
54 reports arrived in the 12 months to August 2026, up 20% from 45 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 (80.7%), injury (18.8%) and death (0.5%); 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 fracture (50.5%), break (48.2%) and fluid/blood leak (31.2%). The patient problems coded most often are device embedded in tissue or plaque, cerebrospinal fluid leakage and fever. 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 |
|---|---|---|---|
| Fracturea broken bone | 110 | 50.5% | 5.7% |
| Breakthe device broke | 105 | 48.2% | 11.2% |
| Fluid/blood leak | 68 | 31.2% | 14.2% |
| Disconnection | 17 | 7.8% | 6.4% |
| Complete blockage | 16 | 7.3% | 0.6% |
| Infusion or flow problema problem with flow or infusion | 12 | 5.5% | 1% |
| Insufficient device problem information | 5 | 2.3% | 1.4% |
| Component missing | 2 | 0.9% | 0.1% |
| Difficult to insertthe device was hard to insert | 2 | 0.9% | 0.7% |
| Device contaminated during manufacture or shipping | 1 | 0.5% | 0% |
| Device markings/labelling problema problem with the device markings or label | 1 | 0.5% | 0% |
| Leak/splashthe device leaked | 1 | 0.5% | 2% |
| Loose or intermittent connection | 1 | 0.5% | 1% |
| Mechanical jam | 1 | 0.5% | 0.3% |
| Migrationthe device moved from where it was placed | 1 | 0.5% | 0% |
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 |
|---|---|---|
| Device embedded in tissue or plaque | 10 | 4.6% |
| Cerebrospinal fluid leakage | 1 | 0.5% |
| Fever | 1 | 0.5% |
| Foreign body in patientpart of a device left in the patient | 1 | 0.5% |
| Hemorrhage/blood loss/bleeding | 1 | 0.5% |
| Intracranial hemorrhage | 1 | 0.5% |
| Irritabilityirritability | 1 | 0.5% |
| Malaisegeneral feeling of being unwell | 1 | 0.5% |
| Muscle weakness/atrophy | 1 | 0.5% |
| Visual impairmentreduced vision | 1 | 0.5% |
| Vomitingbeing sick | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | EDM Lumbar Drainage Kit | Product code GWM | All MAUDE reports |
|---|---|---|---|
| Reports | 218 | 6,858 | 26,136,888 |
| Share of that pool | — | 3.2% | 0% |
| Classified as death, per 1,000 reports | 5 | 12 | 9 |
| Classified as injury | 18.8% | 27.1% | 36.2% |
| Classified as malfunction | 80.7% | 70.9% | 62.3% |
| Filed by the manufacturer | 99.1% | 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% |
| Exacta | 196 | 37 | 2% |
| Olm Intracranial Pressure Monitoring Kit | 180 | 0 | 5% |
| 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 EDM Lumbar Drainage Kit reports
How many FDA reports name EDM Lumbar Drainage Kit?
218 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 54 in the latest 12 months.
What kinds of events are reported?
malfunction (80.7%), injury (18.8%) and death (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fracture (50.5%), break (48.2%), fluid/blood leak (31.2%), disconnection (7.8%) and complete blockage (7.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that EDM Lumbar Drainage 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.