Pump, infusion, implanted, programmable: medical device reports filed with FDA

117,271 reports carry this product code, 1992–2026; 30 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

117,271
reports with this product code: 0.5% of all MAUDE reports; 6,404
reports, 12 months to August 2026: 5,394 in the 12 months before; 32.6%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

Product code LKK is FDA's classification for "Pump, infusion, implanted, programmable" (unknown panel), a class 3 device. 117,271 medical device reports carry this product code, 0.5% of the MAUDE database, from June 1992 to August 2026.

6,404 reports arrived in the 12 months to August 2026, up 19% from 5,394 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 (64%), malfunction (32.6%) and other (1.9%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Synchromed El	7,163	2	4.9%	29.8%
Synchromed	3,401	3	3.2%	35.2%
Indura	2,682	0	0.8%	31.6%
Intrathecal Catheter	695	18	0.1%	12.1%
Implantable Drug Infusion Pump	649	177	0.9%	48.2%
Ascenda	557	14	0.9%	44.9%
Infusion Pump	381	6	3.7%	46.1%
Indura Catheter	373	0	0%	40.5%
Prometra Programmable Pump	348	0	6.6%	31.3%
Intera 3000	307	99	0%	62.9%
Isomed	279	1	2.5%	37.7%
Unknown Implantable Pump	233	0	2.6%	41.2%
N'vision	227	0	0.7%	50.2%
Implantable Infusion Pump	211	0	3.8%	11.4%
Unknown Infusion Pump	157	0	1.9%	36.3%
Catheter	47	9	3.7%	27.9%
Infusaid Implantable Infusion Pump	37	0	3.1%	2.6%
Medtronic	30	17	4.4%	23.5%
Unknown Catheter	22	26	2.2%	38.1%
Pump	17	6	0.2%	39.5%
Tbd	14	8	0.6%	72.7%
Codman	4	0	1.6%	57.9%
Synergy	4	84	3.5%	63.3%
Insulin Pump	2	1	0.5%	42.6%
Capsurefix Mri Surescan	1	0	2.8%	34.5%
Deep Brain Stimulation Lead	1	0	3.8%	32.1%
Implantable Neurostimulator	1	692	0.3%	63.6%
Medtronic Infuse Bone Graft Or Rhbmp2	1	0	0%	0%
Restore Sensor	1	40	0.1%	59%
Sprint Fidelis	1	340	14.1%	12.3%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Puerto Rico Operations	47,223	40.3%
Mdt Puerto Rico Operations	31,812	27.1%
Medtronic Neuromodulation	16,987	14.5%
Rice Creek Manufacturing	6,165	5.3%
Mdt Puerto Rico Operations Juncos	3,241	2.8%
Medtronic	2,918	2.5%
Rice Creek Mfg	2,211	1.9%
Flowonix Medical	1,855	1.6%
Medtronic Puerto Rico Operations Juncos	580	0.5%
Codman & Shurtleff	268	0.2%
Arrow International	94	0.1%
Arrow Intl	77	0.1%
Codman & Shurtleff / Medos	34	0%
Medtronic Med Rel Medtronic Puerto Rico	34	0%
Codman And Shurtleff	26	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death1.4%1,636

Injury64%75,044

Malfunction32.6%38,276

Other1.9%2,213

Not given0.1%102

Who filed

Manufacturer report99.1%116,160

Voluntary report0.6%673

User facility report0%0

Distributor report0%0

Not given0.4%438

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Device operates differently than expectedthe device behaved unexpectedly	9,463	8.1%
Pumping stopped	8,671	7.4%
Insufficient device problem information	8,256	7%
Insufficient flow or under infusion	7,872	6.7%
Migration or expulsion of device	6,739	5.7%
Material integrity problema problem with the device material	6,616	5.6%
Explanted	6,571	5.6%
Infusion or flow problema problem with flow or infusion	5,668	4.8%
Volume accuracy problem	5,407	4.6%
Device displays incorrect message	5,308	4.5%
Improper or incorrect procedure or method	4,642	4%
Communication or transmission problemthe device could not communicate or transmit	4,547	3.9%
Replace	4,096	3.5%
Aspiration issue	3,248	2.8%
Obstruction of flow	3,233	2.8%
Electromagnetic interference	3,110	2.7%
Device remains implanted	2,950	2.5%
Filling problem	2,930	2.5%
Unstable	2,553	2.2%
Failure to service	2,462	2.1%

Questions about pump, infusion, implanted, programmable reports

What is product code LKK?

FDA's classification code for "Pump, infusion, implanted, programmable", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

117,271 reports through August 2026, 6,404 of them in the latest 12 months.

Which brands appear most often?

Synchromed El (7,163), Synchromed (3,401), Indura (2,682), Intrathecal Catheter (695) and Implantable Drug Infusion Pump (649). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.