Device manufacturer, as written on reports

Mdt Puerto Rico Operations Juncos: medical device reports filed with FDA

11,166 reports name it as the manufacturer of the device involved, 2007–2012.

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.

11,166
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 47.6%
classified as malfunction: 62.3% across all reports; 1%
classified as death, as reported: 0.9% across all reports

11,166 medical device reports received by FDA give Mdt Puerto Rico Operations Juncos as the manufacturer of the device involved, 0% of the MAUDE database, from February 2007 to December 2012. 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 (51.2%), malfunction (47.6%) and death (1%). 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
Restore Ultra	Stimulator, spinal-cord, totally implanted for pain relief	1,773	39	0.1%
Soletra	Stimulator, electrical, implanted, for parkinsonian tremor	777	12	4.2%
Restore Prime Advanced	Stimulator, spinal-cord, totally implanted for pain relief	598	0	0.4%
Restore Advanced Rechargeable	Stimulator, spinal-cord, totally implanted for pain relief	529	0	0.6%
Synergy	Coronary drug-eluting stent	459	84	3.5%
Restore Rechargeable Neurostimulator	Stimulator, spinal-cord, totally implanted for pain relief	394	0	1.1%
Interstim	Stimulator, electrical, implantable, for incontinence	382	1,522	0.2%
Restore Rechargable Neurostimulator	Stimulator, spinal-cord, totally implanted for pain relief	320	0	0.6%
Activa Pc	Stimulator, electrical, implanted, for parkinsonian tremor	236	0	1.2%
Kinetra	Stimulator, electrical, implanted, for parkinsonian tremor	230	1	2.1%
Itrel 3	Stimulator, spinal-cord, totally implanted for pain relief	222	10	1.4%
Enterra	Intestinal stimulator	199	0	0.8%
Restore Prime	Stimulator, spinal-cord, totally implanted for pain relief	45	2	1.1%
Restore Sensor	Stimulator, spinal-cord, totally implanted for pain relief	15	40	0.1%
Synergy Versitrel	Stimulator, spinal-cord, totally implanted for pain relief	6	4	0%
Itrel	Stimulator, spinal-cord, implanted (pain relief)	3	0	3.4%
Synchromed	Pump, infusion, implanted, programmable	3	3	3.2%
Synchromed El	Pump, infusion, implanted, programmable	3	2	4.9%
Unknown Spinal Cord Stimulator	Stimulator, spinal-cord, totally implanted for pain relief	2	0	1.2%
Activa	Stimulator, electrical, implanted, for parkinsonian tremor	1	1,112	0.6%
Prostiva	Unit, electrosurgical, endoscopic (with or without accessories)	1	0	2.4%
Pump Mmt-522nal Prdgm Ins V2 2 Cl En	Pump, infusion, insulin	1	0	0.8%

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
LGW	Stimulator, spinal-cord, totally implanted for pain relief	4,460	39.9%
LKK	Pump, infusion, implanted, programmable	3,241	29%
EZW	Stimulator, electrical, implantable, for incontinence	1,874	16.8%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	1,380	12.4%
LNQ	Intestinal stimulator	203	1.8%
LZG	Pump, infusion, insulin	2	0%
ESW	Prosthesis, esophageal	1	0%
GES	Blade, scalpel	1	0%
KNS	Unit, electrosurgical, endoscopic (with or without accessories)	1	0%
LNS	Lithotriptor, extracorporeal shock-wave, urological	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

Death1%110

Injury51.2%5,718

Malfunction47.6%5,317

Other0.1%13

Not given0.1%8

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

Questions about Mdt Puerto Rico Operations Juncos reports

How many FDA device reports name Mdt Puerto Rico Operations Juncos as manufacturer?

11,166 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Restore Ultra (1,773), Soletra (777), Restore Prime Advanced (598), Restore Advanced Rechargeable (529) and Synergy (459).

Which device types does it report on?

stimulator, spinal-cord, totally implanted for pain relief (39.9%), pump, infusion, implanted, programmable (29%), stimulator, electrical, implantable, for incontinence (16.8%) and stimulator, electrical, implanted, for parkinsonian tremor (12.4%).

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.