Devices › Pump, infusion, implanted, programmable
Device brand name · Implantable infusion pump
Synchromed: medical device reports filed with FDA
3,429 reports name it, 1994–2025. Manufacturer given most often on reports: Medtronic Neuromodulation. Product code LKK.
- 3,429
- device reports naming the brand
- 0% of all MAUDE reports · about 106 a year
- 3
- reports, 12 months to August 2026
- 8 in the 12 months before
- 35.2%
- classified as malfunction
- 32.6% across the product code
- 3.2%
- classified as death, as reported
- 111 reports · not verified by FDA
FDA's MAUDE database holds 3,429 reports that name the brand "Synchromed" (implantable infusion pump), received between January 1994 and November 2025; the manufacturer given most often on reports is Medtronic Neuromodulation. Spellings of one product vary from report to report.
3 reports arrived in the 12 months to August 2026, down 62% from 8 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 (48.9%), malfunction (35.2%) and other (12.2%); 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 (31.4%), replace (16%) and device operates differently than expected (7.2%). The patient problems coded most often are surgical procedure, therapeutic response, decreased and surgical procedure, repeated. 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 | 1,076 | 31.4% | 5.6% |
| Replace | 549 | 16% | 3.5% |
| Device operates differently than expectedthe device behaved unexpectedly | 246 | 7.2% | 8.1% |
| Device remains implanted | 168 | 4.9% | 2.5% |
| Insufficient device problem information | 150 | 4.4% | 7% |
| Improper or incorrect procedure or method | 115 | 3.4% | 4% |
| Insufficient flow or under infusion | 107 | 3.1% | 6.7% |
| Battery failure | 98 | 2.9% | 0.3% |
| Failure to infuse | 92 | 2.7% | 0.2% |
| Migration or expulsion of device | 83 | 2.4% | 5.7% |
| Breakthe device broke | 80 | 2.3% | 0.5% |
| Malfunction | 73 | 2.1% | 0.4% |
| Other (for use when an appropriate device code cannot be identified) | 73 | 2.1% | 0.5% |
| Device issuea problem with the device | 72 | 2.1% | 0.3% |
| Failure to pump | 71 | 2.1% | 0.2% |
| Volume accuracy problem | 71 | 2.1% | 4.6% |
| Occlusion within devicethe device blocked | 67 | 2% | 1.8% |
| Pumping stopped | 64 | 1.9% | 7.4% |
| Excess flow or over-infusion | 62 | 1.8% | 1.9% |
| Disconnection | 55 | 1.6% | 1.4% |
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 | 644 | 18.8% |
| Therapeutic response, decreased | 588 | 17.1% |
| Surgical procedure, repeated | 436 | 12.7% |
| Hospitalization required | 361 | 10.5% |
| Therapy/non-surgical treatment, additional | 351 | 10.2% |
| Painpain, site not specified | 309 | 9% |
| Treatment with medication(s) | 270 | 7.9% |
| Other (for use when an appropriate patient code cannot be identified) | 256 | 7.5% |
| Overdosea dose above the recommended amount | 211 | 6.2% |
| Surgical procedure, additional | 146 | 4.3% |
| Muscle spasm(s) | 141 | 4.1% |
| Inadequate pain relief | 129 | 3.8% |
| Deaththe patient died; cause not stated by this term | 104 | 3% |
| Nauseafeeling sick | 92 | 2.7% |
| Underdoseless than the intended dose | 83 | 2.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Synchromed | Product code LKK | All MAUDE reports |
|---|---|---|---|
| Reports | 3,429 | 117,271 | 26,136,888 |
| Share of that pool | — | 2.9% | 0% |
| Classified as death, per 1,000 reports | 32 | 14 | 9 |
| Classified as injury | 48.9% | 64% | 36.2% |
| Classified as malfunction | 35.2% | 32.6% | 62.3% |
| Filed by the manufacturer | 98.6% | 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% |
| 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 reports
How many FDA reports name Synchromed?
3,429 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 3 in the latest 12 months.
What kinds of events are reported?
injury (48.9%), malfunction (35.2%) and other (12.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
explanted (31.4%), replace (16%), device operates differently than expected (7.2%), device remains implanted (4.9%) and insufficient device problem information (4.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.6%) and voluntary reports (0.5%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Synchromed 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.