Devices › Shunt, central nervous system and components
Device brand name · Shunt central nervous system and components
Strata: medical device reports filed with FDA
817 reports name it, 2010–2026. Manufacturer given most often on reports: Medtronic Dominicana. Product code JXG.
- 817
- device reports naming the brand
- 0% of all MAUDE reports · about 50 a year
- 163
- reports, 12 months to August 2026
- 159 in the 12 months before
- 53.6%
- classified as malfunction
- 31.2% across the product code
- 2.2%
- classified as death, as reported
- 18 reports · not verified by FDA
817 medical device reports received by FDA name the brand "Strata" (shunt central nervous system and components); the manufacturer given most often on reports is Medtronic Dominicana; received from March 2010 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
163 reports arrived in the 12 months to August 2026, close to the 159 of 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 (53.6%), injury (44.2%) and death (2.2%); across all shunt, central nervous system and components reports (product code JXG) death is recorded in 0.9% and malfunction in 31.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are infusion or flow problem (21.5%), fluid/blood leak (18%) and insufficient device problem information (13.7%). The patient problems coded most often are headache, intracranial hemorrhage and hematoma. 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 25,520 reports carrying product code JXG. 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 |
|---|---|---|---|
| Infusion or flow problema problem with flow or infusion | 176 | 21.5% | 11% |
| Fluid/blood leak | 147 | 18% | 3% |
| Insufficient device problem information | 112 | 13.7% | 5.2% |
| Mechanics altered | 111 | 13.6% | 1% |
| Complete blockage | 104 | 12.7% | 1.5% |
| Breakthe device broke | 83 | 10.2% | 8.4% |
| Fracturea broken bone | 82 | 10% | 2.6% |
| Mechanical jam | 55 | 6.7% | 0.7% |
| Product quality problem | 30 | 3.7% | 0.2% |
| Disconnection | 19 | 2.3% | 2% |
| Migrationthe device moved from where it was placed | 15 | 1.8% | 0.4% |
| Device dislodged or dislocated | 6 | 0.7% | 0.7% |
| Loose or intermittent connection | 6 | 0.7% | 0.2% |
| Component missing | 1 | 0.1% | 0.1% |
| Defective devicethe device was defective | 1 | 0.1% | 0.4% |
| Device appears to trigger rejection | 1 | 0.1% | 0% |
| Device contaminated during manufacture or shipping | 1 | 0.1% | 0% |
| Device damaged prior to usethe device was damaged before use | 1 | 0.1% | 0.2% |
| Expiration date error | 1 | 0.1% | 0% |
| Lack of effect | 1 | 0.1% | 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 |
|---|---|---|
| Headachehead pain | 54 | 6.6% |
| Intracranial hemorrhage | 25 | 3.1% |
| Hematomaa collection of blood under the skin or in tissue | 23 | 2.8% |
| Vomitingbeing sick | 18 | 2.2% |
| Cognitive changes | 17 | 2.1% |
| Ambulation or postural difficulties | 15 | 1.8% |
| Convulsion/seizure | 14 | 1.7% |
| Hydrocephalus | 13 | 1.6% |
| Painpain, site not specified | 12 | 1.5% |
| Cerebrospinal fluid leakage | 11 | 1.3% |
| Visual impairmentreduced vision | 11 | 1.3% |
| Bacterial infectiona bacterial infection | 9 | 1.1% |
| Dizzinesslight-headedness or unsteadiness | 9 | 1.1% |
| Hemorrhage/blood loss/bleeding | 9 | 1.1% |
| Nauseafeeling sick | 9 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Strata | Product code JXG | All MAUDE reports |
|---|---|---|---|
| Reports | 817 | 25,520 | 26,136,888 |
| Share of that pool | — | 3.2% | 0% |
| Classified as death, per 1,000 reports | 22 | 9 | 9 |
| Classified as injury | 44.2% | 64% | 36.2% |
| Classified as malfunction | 53.6% | 31.2% | 62.3% |
| Filed by the manufacturer | 99.3% | 95.1% | 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 JXG
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Hakim Programmable Valve With Prechamber | 948 | 0 | 0.3% |
| Hakim Programmable Valve | 693 | 9 | 0.9% |
| Unknown Strata Valve/Shunt | 515 | 0 | 2.3% |
| Hakim Inline Programmable Valve Sg | 343 | 0 | 0% |
| Certas Inlin Vlv Sphn/Unit Cat | 337 | 0 | 0.6% |
| Hakim Valve | 337 | 0 | 0% |
| Certas Inlin Vlv Only W/Sphngd | 327 | 0 | 0.9% |
| NT821731C, EDS 3, GEN ll, NO CATHETER | 326 | 127 | 0% |
| Unknown Valve/Shunt | 225 | 10 | 5.8% |
| Prog Valve Inline W Sg | 222 | 10 | 0% |
| Hakim Prog Valve Inline Siphonguard | 210 | 0 | 0.5% |
| Programmable Valve In-Line W/Siphonguard | 186 | 0 | 0% |
| Progav 2 0 Valve | 183 | 21 | 0% |
| Unknown Catheter | 270 | 26 | 2.2% |
| Strata 2 Adjustable Valve Regular | 174 | 0 | 0.6% |
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 Strata reports
How many FDA reports name Strata?
817 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 163 in the latest 12 months.
What kinds of events are reported?
malfunction (53.6%), injury (44.2%) and death (2.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
infusion or flow problem (21.5%), fluid/blood leak (18%), insufficient device problem information (13.7%), mechanics altered (13.6%) and complete blockage (12.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.3%) and voluntary reports (0.2%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Strata 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.