Devices › Pump, infusion, implanted, programmable
Device brand name · Pump infusion implanted programmable
Unknown Implantable Pump: medical device reports filed with FDA
233 reports name it, 2012–2019. Manufacturer given most often on reports: Medtronic Neuromodulation. Product code LKK.
- 233
- device reports naming the brand
- 0% of all MAUDE reports · about 17 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 41.2%
- classified as malfunction
- 32.6% across the product code
- 2.6%
- classified as death, as reported
- 6 reports · not verified by FDA
233 medical device reports received by FDA name the brand "Unknown Implantable Pump" (pump infusion implanted programmable); the manufacturer given most often on reports is Medtronic Neuromodulation; received from June 2012 to June 2019. 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, and none 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 (56.2%), malfunction (41.2%) and death (2.6%); 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 (23.6%), device displays incorrect message (9%) and material integrity problem (6.4%). The patient problems coded most often are therapeutic response, decreased, complaint, ill-defined and overdose. 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
No report naming Unknown Implantable Pump was received in the five years to August 2026; the latest was received in June 2019.
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 | 55 | 23.6% | 8.1% |
| Device displays incorrect message | 21 | 9% | 4.5% |
| Material integrity problema problem with the device material | 15 | 6.4% | 5.6% |
| Improper or incorrect procedure or method | 14 | 6% | 4% |
| Failure to service | 9 | 3.9% | 2.1% |
| Occlusion within devicethe device blocked | 7 | 3% | 1.8% |
| Volume accuracy problem | 7 | 3% | 4.6% |
| Filling problem | 6 | 2.6% | 2.5% |
| Intermittent infusion | 6 | 2.6% | 1.7% |
| Aspiration issue | 5 | 2.1% | 2.8% |
| Battery problema problem with the battery | 5 | 2.1% | 0.6% |
| Fluid/blood leak | 5 | 2.1% | 2.1% |
| Unstable | 5 | 2.1% | 2.2% |
| Pumping stopped | 4 | 1.7% | 7.4% |
| Communication or transmission problemthe device could not communicate or transmit | 3 | 1.3% | 3.9% |
| Device ingredient or reagent problem | 3 | 1.3% | 0.4% |
| Device or device fragments location unknown | 3 | 1.3% | 0.6% |
| Connection problema connection problem | 2 | 0.9% | 0.2% |
| Disconnection | 2 | 0.9% | 1.4% |
| Excess flow or over-infusion | 2 | 0.9% | 1.9% |
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 |
|---|---|---|
| Therapeutic response, decreased | 25 | 10.7% |
| Complaint, ill-defined | 22 | 9.4% |
| Overdosea dose above the recommended amount | 17 | 7.3% |
| Painpain, site not specified | 10 | 4.3% |
| Deaththe patient died; cause not stated by this term | 5 | 2.1% |
| Muscular rigidity | 5 | 2.1% |
| Underdoseless than the intended dose | 5 | 2.1% |
| Cerebrospinal fluid leakage | 4 | 1.7% |
| Injurya physical injury | 4 | 1.7% |
| Nauseafeeling sick | 4 | 1.7% |
| Therapeutic effects, unexpected | 4 | 1.7% |
| Ambulation or postural difficulties | 3 | 1.3% |
| Malaisegeneral feeling of being unwell | 3 | 1.3% |
| Tachycardiafast heart rate | 3 | 1.3% |
| Cardiopulmonary arrest | 2 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Unknown Implantable Pump | Product code LKK | All MAUDE reports |
|---|---|---|---|
| Reports | 233 | 117,271 | 26,136,888 |
| Share of that pool | — | 0.2% | 0% |
| Classified as death, per 1,000 reports | 26 | 14 | 9 |
| Classified as injury | 56.2% | 64% | 36.2% |
| Classified as malfunction | 41.2% | 32.6% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| Prometra Programmable Pump | 348 | 0 | 6.6% |
| Intera 3000 | 307 | 99 | 0% |
| Isomed | 281 | 1 | 2.5% |
| 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 Unknown Implantable Pump reports
How many FDA reports name Unknown Implantable Pump?
233 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 (56.2%), malfunction (41.2%) and death (2.6%). "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 (23.6%), device displays incorrect message (9%), material integrity problem (6.4%), improper or incorrect procedure or method (6%) and failure to service (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Unknown Implantable 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.