Devices › Pump, infusion, implanted, programmable
Device brand name · Pump
Synchromed El: medical device reports filed with FDA
7,189 reports name it, 2000–2025. Manufacturer given most often on reports: Rice Creek Manufacturing. Product code LKK.
- 7,189
- device reports naming the brand
- 0% of all MAUDE reports · about 273 a year
- 2
- reports, 12 months to August 2026
- 5 in the 12 months before
- 29.8%
- classified as malfunction
- 32.6% across the product code
- 4.9%
- classified as death, as reported
- 349 reports · not verified by FDA
FDA's MAUDE database holds 7,189 reports that name the brand "Synchromed El" (pump), received between March 2000 and November 2025; the manufacturer given most often on reports is Rice Creek Manufacturing. Spellings of one product vary from report to report.
2 reports arrived in the 12 months to August 2026, down 60% from 5 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 (48.7%), malfunction (29.8%) and other (16.4%); across all pump, infusion, implanted, programmable reports (product code LKK) death is recorded in 1.4% and malfunction in 32.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are explanted (37.4%), replace (20.2%) and device remains implanted (13.1%). The patient problems coded most often are surgical procedure, hospitalization required and therapeutic response, decreased. 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 117,271 reports carrying product code LKK. 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 | 2,687 | 37.4% | 5.6% |
| Replace | 1,455 | 20.2% | 3.5% |
| Device remains implanted | 939 | 13.1% | 2.5% |
| Volume accuracy problem | 478 | 6.6% | 4.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 370 | 5.1% | 8.1% |
| Insufficient flow or under infusion | 321 | 4.5% | 6.7% |
| Insufficient device problem information | 237 | 3.3% | 7% |
| Improper or incorrect procedure or method | 196 | 2.7% | 4% |
| Malfunction | 196 | 2.7% | 0.4% |
| Battery failure | 188 | 2.6% | 0.3% |
| Other (for use when an appropriate device code cannot be identified) | 161 | 2.2% | 0.5% |
| Device displays incorrect message | 135 | 1.9% | 4.5% |
| Low battery | 132 | 1.8% | 0.3% |
| Device issuea problem with the device | 130 | 1.8% | 0.3% |
| Premature explantation | 130 | 1.8% | 0.3% |
| Pumping stopped | 126 | 1.8% | 7.4% |
| Alarm, audible | 112 | 1.6% | 0.3% |
| Occlusion within devicethe device blocked | 100 | 1.4% | 1.8% |
| Excess flow or over-infusion | 97 | 1.3% | 1.9% |
| Migration or expulsion of device | 92 | 1.3% | 5.7% |
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 | 2,528 | 35.2% |
| Hospitalization required | 1,556 | 21.6% |
| Therapeutic response, decreased | 1,500 | 20.9% |
| Painpain, site not specified | 733 | 10.2% |
| Treatment with medication(s) | 704 | 9.8% |
| Surgical procedure, repeated | 692 | 9.6% |
| Therapy/non-surgical treatment, additional | 419 | 5.8% |
| Overdosea dose above the recommended amount | 415 | 5.8% |
| Inadequate pain relief | 376 | 5.2% |
| Other (for use when an appropriate patient code cannot be identified) | 340 | 4.7% |
| Deaththe patient died; cause not stated by this term | 333 | 4.6% |
| Surgical procedure, additional | 312 | 4.3% |
| Underdoseless than the intended dose | 267 | 3.7% |
| Nauseafeeling sick | 263 | 3.7% |
| Muscle spasm(s) | 224 | 3.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Synchromed El | Product code LKK | All MAUDE reports |
|---|---|---|---|
| Reports | 7,189 | 117,271 | 26,136,888 |
| Share of that pool | — | 6.1% | 0% |
| Classified as death, per 1,000 reports | 49 | 14 | 9 |
| Classified as injury | 48.7% | 64% | 36.2% |
| Classified as malfunction | 29.8% | 32.6% | 62.3% |
| Filed by the manufacturer | 99.7% | 99.1% | 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 LKK
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Synchromed | 3,429 | 3 | 3.2% |
| Indura | 2,730 | 0 | 0.8% |
| Intrathecal Catheter | 696 | 18 | 0.1% |
| Implantable Drug Infusion Pump | 649 | 177 | 0.9% |
| Ascenda | 570 | 14 | 0.9% |
| Infusion Pump | 830 | 6 | 3.7% |
| Indura Catheter | 373 | 0 | 0% |
| Prometra Programmable Pump | 348 | 0 | 6.6% |
| Intera 3000 | 307 | 99 | 0% |
| Isomed | 281 | 1 | 2.5% |
| Unknown Implantable Pump | 233 | 0 | 2.6% |
| N'vision | 269 | 0 | 0.7% |
| Implantable Infusion Pump | 211 | 0 | 3.8% |
| Unknown Infusion Pump | 157 | 0 | 1.9% |
| Catheter | 244 | 9 | 3.7% |
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 Synchromed El reports
How many FDA reports name Synchromed El?
7,189 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 2 in the latest 12 months.
What kinds of events are reported?
injury (48.7%), malfunction (29.8%) and other (16.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (37.4%), replace (20.2%), device remains implanted (13.1%), volume accuracy problem (6.6%) and device operates differently than expected (5.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Synchromed El 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.