Devices › Shunt, central nervous system and components
Device brand name · Cns shunt
Hakim Programmable Valve: medical device reports filed with FDA
693 reports name it, 1998–2025. Manufacturer given most often on reports: Integra Lifesciences Switzerland Sar. Product code JXG.
- 693
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 9
- reports, 12 months to August 2026
- 20 in the 12 months before
- 9.1%
- classified as malfunction
- 31.2% across the product code
- 0.9%
- classified as death, as reported
- 6 reports · not verified by FDA
693 medical device reports received by FDA name the brand "Hakim Programmable Valve" (cns shunt); the manufacturer given most often on reports is Integra Lifesciences Switzerland Sar; received from September 1998 to November 2025. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
9 reports arrived in the 12 months to August 2026, down 55% from 20 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 injury (89.8%), malfunction (9.1%) and death (0.9%); 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 explanted (25%), program, failure to (14.3%) and other (for use when an appropriate device code cannot be identified) (14%). The patient problems coded most often are surgical procedure, other (for use when an appropriate patient code cannot be identified) and surgical procedure, additional. 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 |
|---|---|---|---|
| Explanted | 173 | 25% | 10.6% |
| Program, failure to | 99 | 14.3% | 2.4% |
| Other (for use when an appropriate device code cannot be identified) | 97 | 14% | 6% |
| Replace | 50 | 7.2% | 4.2% |
| Obstruction of flow | 41 | 5.9% | 5.8% |
| Partial blockage | 41 | 5.9% | 2.4% |
| Valve(s), failure of | 36 | 5.2% | 2.1% |
| Programming issue | 33 | 4.8% | 1.9% |
| Insufficient device problem information | 31 | 4.5% | 5.2% |
| Mechanical problema mechanical problem | 28 | 4% | 5.1% |
| Infusion or flow problema problem with flow or infusion | 25 | 3.6% | 11% |
| Device difficult to program or calibrate | 23 | 3.3% | 1% |
| Device dislodged or dislocated | 23 | 3.3% | 0.7% |
| Pressure problem | 21 | 3% | 1.3% |
| Breakthe device broke | 20 | 2.9% | 8.4% |
| Output problem | 16 | 2.3% | 0.5% |
| Restricted flow rate | 16 | 2.3% | 1.4% |
| Occlusion within devicethe device blocked | 13 | 1.9% | 3.9% |
| Device issuea problem with the device | 10 | 1.4% | 1.7% |
| No flow | 10 | 1.4% | 1.7% |
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 |
|---|---|---|
| Surgical procedure | 116 | 16.7% |
| Other (for use when an appropriate patient code cannot be identified) | 100 | 14.4% |
| Surgical procedure, additional | 97 | 14% |
| Failure of implant | 55 | 7.9% |
| Surgical procedure, repeated | 55 | 7.9% |
| Injurya physical injury | 49 | 7.1% |
| Headachehead pain | 47 | 6.8% |
| Vomitingbeing sick | 18 | 2.6% |
| Hydrocephalus | 16 | 2.3% |
| Therapy/non-surgical treatment, additional | 12 | 1.7% |
| Cerebral ventriculomegaly | 10 | 1.4% |
| Nauseafeeling sick | 9 | 1.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 8 | 1.2% |
| Convulsion/seizure | 7 | 1% |
| Ambulation or postural difficulties | 6 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hakim Programmable Valve | Product code JXG | All MAUDE reports |
|---|---|---|---|
| Reports | 693 | 25,520 | 26,136,888 |
| Share of that pool | — | 2.7% | 0% |
| Classified as death, per 1,000 reports | 9 | 9 | 9 |
| Classified as injury | 89.8% | 64% | 36.2% |
| Classified as malfunction | 9.1% | 31.2% | 62.3% |
| Filed by the manufacturer | 99.4% | 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% |
| Strata | 817 | 163 | 2.2% |
| 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 Hakim Programmable Valve reports
How many FDA reports name Hakim Programmable Valve?
693 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 9 in the latest 12 months.
What kinds of events are reported?
injury (89.8%), malfunction (9.1%) and death (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (25%), program, failure to (14.3%), other (for use when an appropriate device code cannot be identified) (14%), replace (7.2%) and obstruction of flow (5.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.4%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Hakim Programmable Valve 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.