Device manufacturer, as written on reports

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

88,060 reports name it as the manufacturer of the device involved, 2007–2025.

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.

88,060
reports naming it as manufacturer: 0.3% of all MAUDE reports; 0
reports, 12 months to August 2026: 560 in the 12 months before; 43.5%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

88,060 medical device reports received by FDA give Medtronic Med Rel Medtronic Puerto Rico as the manufacturer of the device involved, 0.3% of the MAUDE database, from January 2007 to July 2025. 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, against 560 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 (55.2%), malfunction (43.5%) and death (1.4%). 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	9,677	39	0.1%
Restore Sensor	Stimulator, spinal-cord, totally implanted for pain relief	8,707	40	0.1%
Activa	Stimulator, electrical, implanted, for parkinsonian tremor	6,872	1,112	0.6%
SureScan	Stimulator, spinal-cord, totally implanted for pain relief	3,855	490	0%
Primeadvanced	Stimulator, spinal-cord, totally implanted for pain relief	3,445	16	0%
Restore Advanced	Stimulator, spinal-cord, totally implanted for pain relief	3,196	18	0.1%
Restore	Stimulator, spinal-cord, totally implanted for pain relief	2,626	27	0.1%
Consulta Crt-D	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	2,597	0	5.9%
Protecta Xt Crt-D	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	2,288	3	4.5%
Adapta	Pulse generator, permanent, implantable	2,083	279	7.4%
Soletra	Stimulator, electrical, implanted, for parkinsonian tremor	1,663	12	4.2%
Interstim	Stimulator, electrical, implantable, for incontinence	1,423	1,522	0.2%
Revo MRI SureScan	Implantable pulse generator, pacemaker (non-crt)	1,359	12	2.9%
Enterra	Intestinal stimulator	1,102	0	0.8%
Synergy	Coronary drug-eluting stent	977	84	3.5%
Reveal Xt	Detector and alarm, arrhythmia	700	0	0.1%
Kinetra	Stimulator, electrical, implanted, for parkinsonian tremor	602	1	2.1%
Virtuoso	Implantable cardioverter defibrillator (non-crt)	560	0	2.7%
Itrel 3	Stimulator, spinal-cord, totally implanted for pain relief	523	10	1.4%
Viva Xt	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	478	0	4.6%
Virtuoso Vr	Implantable cardioverter defibrillator (non-crt)	434	0	4.7%
Sensia IPG	Pulse generator, permanent, implantable	384	73	2.7%
Enrhythm	Pulse generator, permanent, implantable	281	0	9.9%
Protecta Crt-D	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	266	0	2.7%
Versa Ipg	Pulse generator, permanent, implantable	202	12	8.1%
Advisa MRI SureScan	Pulse generator, permanent, implantable	178	272	1.9%
Protecta XT VR	Implantable cardioverter defibrillator (non-crt)	167	8	5.3%
Evera Xt Vr	Implantable cardioverter defibrillator (non-crt)	150	91	4.1%
Viva XT CRT-D	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	90	38	1.8%
Secura Vr	Implantable cardioverter defibrillator (non-crt)	71	0	8.8%

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	33,763	38.3%
EZW	Stimulator, electrical, implantable, for incontinence	16,486	18.7%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	8,808	10%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	8,310	9.4%
LWS	Implantable cardioverter defibrillator (non-crt)	8,109	9.2%
NVZ	Pulse generator, permanent, implantable	7,864	8.9%
LWP	Implantable pulse generator, pacemaker (non-crt)	1,405	1.6%
LNQ	Intestinal stimulator	1,095	1.2%
DSI	Detector and alarm, arrhythmia	849	1%
MRU	Implanted subcortical electrical stimulator (motor disorders)	559	0.6%

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

Death1.4%1,204

Injury55.2%48,588

Malfunction43.5%38,267

Other0%0

Not given0%1

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

Questions about Medtronic Med Rel Medtronic Puerto Rico reports

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

88,060 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Restore Ultra (9,677), Restore Sensor (8,707), Activa (6,872), SureScan (3,855) and Primeadvanced (3,445).

Which device types does it report on?

stimulator, spinal-cord, totally implanted for pain relief (38.3%), stimulator, electrical, implantable, for incontinence (18.7%), defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (10%) and stimulator, electrical, implanted, for parkinsonian tremor (9.4%).

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.