Device manufacturer, as written on reports

Medtronic Europe Sarl: medical device reports filed with FDA

46,008 reports name it as the manufacturer of the device involved, 2004–2026.

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.

46,008
reports naming it as manufacturer: 0.2% of all MAUDE reports; 5,360
reports, 12 months to August 2026: 5,225 in the 12 months before; 59.8%
classified as malfunction: 62.3% across all reports; 1.3%
classified as death, as reported: 0.9% across all reports

46,008 medical device reports received by FDA give Medtronic Europe Sarl as the manufacturer of the device involved, 0.2% of the MAUDE database, from March 2004 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

5,360 reports arrived in the 12 months to August 2026, close to the 5,225 of 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 malfunction (59.8%), injury (38.9%) and death (1.3%). 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
Reveal LINQ	Detector and alarm, arrhythmia	12,224	264	0%
Cobalt XT HF Quad CRT-D MRI SureScan	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	2,557	791	3%
Claria MRI Quad CRT-D SureScan	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	1,864	274	2.2%
Cobalt HF Quad CRT-D MRI SureScan	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	1,098	183	2.8%
Percepta Quad CRT-P MRI SureScan	Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)	1,056	261	2.3%
Cobalt XT HF CRT-D MRI SureScan	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	922	317	3.3%
Visia AF MRI XT VR SureScan	Implantable cardioverter defibrillator (non-crt)	890	325	1.6%
Cobalt XT VR MRI SureScan	Implantable cardioverter defibrillator (non-crt)	818	272	1.3%
Claria MRI CRT-D SureScan	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	770	97	2%
Amplia MRI Quad CRT-D SureScan	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	654	81	2.2%
Aurora EV-ICD MRI SureScan	Implantable cardioverter defibrillator (non-crt)	604	337	2.2%
Advisa MRI SureScan	Pulse generator, permanent, implantable	516	272	1.9%
Cobalt VR MRI SureScan	Implantable cardioverter defibrillator (non-crt)	424	68	2.4%
Amplia MRI CRT-D SureScan	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	410	58	1.3%
Cobalt HF CRT-D MRI SureScan	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	381	57	2.3%
Percepta CRT-P MRI SureScan	Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)	353	97	1.3%
Activa	Stimulator, electrical, implanted, for parkinsonian tremor	346	1,112	0.6%
Compia MRI Quad CRT-D SureScan	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	277	38	1.3%
Adapta	Pulse generator, permanent, implantable	202	279	7.4%
Kinetra	Stimulator, electrical, implanted, for parkinsonian tremor	179	1	2.1%
Azure	Pulse generator, permanent, implantable	171	0	1.8%
Viva XT CRT-D	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	167	38	1.8%
Consulta Crt-P	Pulse generator, permanent, implantable	164	5	4.7%
Viva Quad XT CRT-D	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	162	24	2%
Evera S VR	Implantable cardioverter defibrillator (non-crt)	159	53	3%
Viva Xt	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	159	0	4.6%
Protecta Xt Crt-D	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	136	3	4.5%
Viva Quad Xt	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	134	0	3.8%
Evera MRI S VR SureScan	Implantable cardioverter defibrillator (non-crt)	121	24	2.6%
Visia AF MRI S VR SureScan	Implantable cardioverter defibrillator (non-crt)	113	34	1.3%

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
DSI	Detector and alarm, arrhythmia	12,377	26.9%
LWS	Implantable cardioverter defibrillator (non-crt)	12,356	26.9%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	11,814	25.7%
NVZ	Pulse generator, permanent, implantable	5,439	11.8%
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)	2,207	4.8%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	707	1.5%
LGW	Stimulator, spinal-cord, totally implanted for pain relief	359	0.8%
LWP	Implantable pulse generator, pacemaker (non-crt)	245	0.5%
DXY	Implantable pacemaker pulse-generator	235	0.5%
EZW	Stimulator, electrical, implantable, for incontinence	107	0.2%

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

Death1.3%602

Injury38.9%17,885

Malfunction59.8%27,499

Other0%21

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 Europe Sarl reports

How many FDA device reports name Medtronic Europe Sarl as manufacturer?

46,008 reports through August 2026, 5,360 of them in the latest 12 months.

Which of its brands appear most often?

Reveal LINQ (12,224), Cobalt XT HF Quad CRT-D MRI SureScan (2,557), Claria MRI Quad CRT-D SureScan (1,864), Cobalt HF Quad CRT-D MRI SureScan (1,098) and Percepta Quad CRT-P MRI SureScan (1,056).

Which device types does it report on?

detector and alarm, arrhythmia (26.9%), implantable cardioverter defibrillator (non-crt) (26.9%), defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (25.7%) and pulse generator, permanent, implantable (11.8%).

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.