Device manufacturer, as written on reports

Medtronic Puerto Rico Operations Med-Rel: medical device reports filed with FDA

10,804 reports name it as the manufacturer of the device involved, 2006–2011.

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.

10,804
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 37.5%
classified as malfunction: 62.3% across all reports; 2.2%
classified as death, as reported: 0.9% across all reports

10,804 medical device reports received by FDA give Medtronic Puerto Rico Operations Med-Rel as the manufacturer of the device involved, 0% of the MAUDE database, from June 2006 to October 2011. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

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 (60.1%), malfunction (37.5%) and death (2.2%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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 named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Paradigm Real-Time Insulin Infusion Pump	Pump, infusion, insulin, to be used with invasive glucose sensor	1,389	0	0.3%
Pump Mmt-722nas Prdgm Ins V2 2 Sk En	Pump, infusion, insulin	1,341	0	2.6%
Paradigm Real-Time Revel Insulin Infusion Pump	Pump, infusion, insulin, to be used with invasive glucose sensor	723	0	0.6%
Pump Mmt-522nas Prdgm Ins V2 2 Sk En	Pump, infusion, insulin	691	0	3.5%
Pump Mmt-722nab Prdgm Ins V2 2 Bl En	Pump, infusion, insulin	588	0	2.1%
Pump Mmt-722nal Prdgm Ins V2 2 Cl En Pr	Pump, infusion, insulin	569	0	2%
Pump Mmt-722nap Prdgm Ins V2 2 Pl En	Pump, infusion, insulin	522	0	2.8%
Pump Mmt-522nal Prdgm Ins V2 2 Cl En	Pump, infusion, insulin	419	0	0.8%
Rsvr Mmt-326a 10pk Prdgm 1 8ml 13l	Syringe, piston	377	0	0.4%
Pump Mmt-522nab Prdgm Ins V2 2 Bl En	Pump, infusion, insulin	288	0	1.7%
Pump Mmt-522nap Prdgm Ins V2 2 Pl En	Pump, infusion, insulin	275	0	1.7%
Pump Mmt-715nas Prdgm Ins V2 1 Sk En	Pump, infusion, insulin	210	0	5.1%
Rsvr Mmt-332a 10pk Prdgm 3cc 14l	Syringe, piston	204	0	0.7%
Reservoir 1 8 Ml	Pump, infusion	186	0	0.9%
Paradigm Insulin Infusion Pump	Pump, infusion, insulin	163	0	0.4%
Reservoir 3cc	Pump, infusion	132	0	3.6%
Reservoir 3ml	Pump, infusion	95	0	0.8%
Pump Mmt-515nas Prdgm Ins V2 1 Sk En	Pump, infusion, insulin	88	0	5.2%
Pump Mmt-715nal Prdgm Ins V2 1 Cl En	Pump, infusion, insulin	75	0	3.9%
Paradigm Real-Time Insulin Infusion Pump Mmt-722nas	Pump, infusion, insulin, to be used with invasive glucose sensor	27	8	1.5%
Paradigm Model Mmt-715 Smoke	Pump, infusion, insulin	21	0	1.6%
Paradigm Real-Time Insulin Infusion Pump Mmt-522nas	Pump, infusion, insulin, to be used with invasive glucose sensor	15	0	3%
Paradigm Real-Time Insulin Infusion Pump Mmt-722nab	Pump, infusion, insulin, to be used with invasive glucose sensor	12	2	2.1%
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723nas	Pump, infusion, insulin, to be used with invasive glucose sensor	10	49	0.8%
Paradigm Real-Time Insulin Infusion Pump Mmt-722nall	Pump, infusion, insulin, to be used with invasive glucose sensor	8	1	0.6%
Reservoir 1 8ml	Pump, infusion	7	0	0.1%
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723nah	Pump, infusion, insulin, to be used with invasive glucose sensor	5	0	0.5%
Pump Mmt-515lnas Prdgm Ins V2 1 Sk En	Pump, infusion, insulin	5	0	2.4%
Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723NAB	Pump, infusion, insulin, to be used with invasive glucose sensor	4	9	0.8%
Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723NAP	Pump, infusion, insulin, to be used with invasive glucose sensor	4	11	0.5%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
LZG	Pump, infusion, insulin	6,010	55.6%
MDS	Sensor, glucose, invasive	3,552	32.9%
FMF	Syringe, piston	566	5.2%
FRN	Pump, infusion	533	4.9%
OYC	Pump, infusion, insulin, to be used with invasive glucose sensor	109	1%
CGA	Glucose oxidase, glucose	24	0.2%
LGZ	Warmer, thermal, infusion fluid	3	0%
EZW	Stimulator, electrical, implantable, for incontinence	2	0%
LGW	Stimulator, spinal-cord, totally implanted for pain relief	2	0%
LKK	Pump, infusion, implanted, programmable	1	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

Death2.2%242

Injury60.1%6,494

Malfunction37.5%4,054

Other0%2

Not given0.1%12

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Medtronic Puerto Rico Operations Med-Rel reports

How many FDA device reports name Medtronic Puerto Rico Operations Med-Rel as manufacturer?

10,804 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Paradigm Real-Time Insulin Infusion Pump (1,389), Pump Mmt-722nas Prdgm Ins V2 2 Sk En (1,341), Paradigm Real-Time Revel Insulin Infusion Pump (723), Pump Mmt-522nas Prdgm Ins V2 2 Sk En (691) and Pump Mmt-722nab Prdgm Ins V2 2 Bl En (588).

Which device types does it report on?

pump, infusion, insulin (55.6%), sensor, glucose, invasive (32.9%), syringe, piston (5.2%) and pump, infusion (4.9%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.