Devices › Pump, infusion, implanted, programmable
Device brand name · Implantable infusion pump
Prometra Programmable Pump: medical device reports filed with FDA
348 reports name it, 2012–2025. Manufacturer given most often on reports: Flowonix Medical. Product code LKK.
- 348
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 0
- reports, 12 months to August 2026
- 7 in the 12 months before
- 31.3%
- classified as malfunction
- 32.6% across the product code
- 6.6%
- classified as death, as reported
- 23 reports · not verified by FDA
348 medical device reports received by FDA name the brand "Prometra Programmable Pump" (implantable infusion pump); the manufacturer given most often on reports is Flowonix Medical; received from October 2012 to August 2025. 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, against 7 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 (62.1%), malfunction (31.3%) and death (6.6%); 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 device operates differently than expected (25.6%), insufficient flow or under infusion (9.8%) and device displays incorrect message (8.3%). The patient problems coded most often are inadequate pain relief, pain and death. 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 |
|---|---|---|---|
| Device operates differently than expectedthe device behaved unexpectedly | 89 | 25.6% | 8.1% |
| Insufficient flow or under infusion | 34 | 9.8% | 6.7% |
| Device displays incorrect message | 29 | 8.3% | 4.5% |
| Insufficient device problem information | 18 | 5.2% | 7% |
| Device issuea problem with the device | 12 | 3.4% | 0.3% |
| Migration or expulsion of device | 5 | 1.4% | 5.7% |
| Excess flow or over-infusion | 4 | 1.1% | 1.9% |
| Extrusion | 4 | 1.1% | 0% |
| Wireless communication problema wireless connection problem | 4 | 1.1% | 0% |
| Communication or transmission problemthe device could not communicate or transmit | 3 | 0.9% | 3.9% |
| Device operational issue | 2 | 0.6% | 0.1% |
| No flow | 2 | 0.6% | 0.1% |
| Unexpected therapeutic results | 2 | 0.6% | 0% |
| Breakthe device broke | 1 | 0.3% | 0.5% |
| Coiled | 1 | 0.3% | 0.1% |
| Defective devicethe device was defective | 1 | 0.3% | 0.1% |
| Detachment of device or device componentpart of the device came off | 1 | 0.3% | 0% |
| Expulsion | 1 | 0.3% | 0% |
| Inaccurate delivery | 1 | 0.3% | 0.1% |
| Infusion or flow problema problem with flow or infusion | 1 | 0.3% | 4.8% |
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 |
|---|---|---|
| Inadequate pain relief | 76 | 21.8% |
| Painpain, site not specified | 27 | 7.8% |
| Deaththe patient died; cause not stated by this term | 26 | 7.5% |
| Discomfortdiscomfort | 8 | 2.3% |
| Overdosea dose above the recommended amount | 8 | 2.3% |
| Loss of consciousnesspassing out | 5 | 1.4% |
| Muscle spasm(s) | 4 | 1.1% |
| No patient involvement | 4 | 1.1% |
| Oversedation | 4 | 1.1% |
| Cerebrospinal fluid leakage | 3 | 0.9% |
| Missing value reason | 3 | 0.9% |
| Nauseafeeling sick | 3 | 0.9% |
| Sedationdrowsiness from a medicine | 3 | 0.9% |
| Seromaa collection of fluid under the skin | 3 | 0.9% |
| Abrasion | 2 | 0.6% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Prometra Programmable Pump | Product code LKK | All MAUDE reports |
|---|---|---|---|
| Reports | 348 | 117,271 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 66 | 14 | 9 |
| Classified as injury | 62.1% | 64% | 36.2% |
| Classified as malfunction | 31.3% | 32.6% | 62.3% |
| Filed by the manufacturer | 97.7% | 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 El | 7,189 | 2 | 4.9% |
| 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% |
| 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 Prometra Programmable Pump reports
How many FDA reports name Prometra Programmable Pump?
348 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?
injury (62.1%), malfunction (31.3%) and death (6.6%). "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 (25.6%), insufficient flow or under infusion (9.8%), device displays incorrect message (8.3%), insufficient device problem information (5.2%) and device issue (3.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (97.7%) and voluntary reports (2.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Prometra Programmable Pump 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.