Device manufacturer, as written on reports

Medtronic: medical device reports filed with FDA

155,418 reports name it as the manufacturer of the device involved, 1992–2026.

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.

155,418
reports naming it as manufacturer: 0.6% of all MAUDE reports; 61,714
reports, 12 months to August 2026: 7,356 in the 12 months before; 74.6%
classified as malfunction: 62.3% across all reports; 1.8%
classified as death, as reported: 0.9% across all reports

155,418 medical device reports received by FDA give Medtronic as the manufacturer of the device involved, 0.6% of the MAUDE database, from January 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

61,714 reports arrived in the 12 months to August 2026, up 739% from 7,356 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 malfunction (74.6%), injury (22.6%) and death (1.8%). 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
CareLink SmartSync Common App iOS	Pacemaker/icd/crt non-implanted components	56,769	55,695	0%
Carelink	Programmer, pacemaker	12,832	18	0%
Carelink Programmer	Programmer, pacemaker	6,249	546	0%
Dual Chamber Temporary Pacemaker	Pulse-generator, pacemaker, external	4,007	518	0.3%
Permanent Pacemaker Electrode	Permanent pacemaker electrode	2,975	332	0.4%
Medtronic	Implantable cardioverter defibrillator (non-crt)	2,208	17	4.4%
Medtronic Lead	Implantable pacemaker pulse-generator	2,119	328	9.5%
Drug Eluting Permanent Right Ventricular Rv Or Right Atrial Ra Pacemaker Ele	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	1,767	405	0.3%
Implantable Cardioverter Defibrillator Non-Crt	Implantable cardioverter defibrillator (non-crt)	1,709	197	0.5%
CareLink SmartSync Base	Analyzer, pacemaker generator function	1,682	227	0%
Carelink Program W/Telemetry C	Implantable pacemaker pulse-generator	1,651	0	0%
CapSure Epicardial Lead	Permanent pacemaker electrode	1,437	760	1.5%
Synchromed	Pump, infusion, implanted, programmable	1,325	3	3.2%
Capsureepi	Permanent pacemaker electrode	1,302	0	2.4%
Capsure EPI	Permanent pacemaker electrode	1,227	0	7%
Permanent Defibrillator Electrodes	Permanent defibrillator electrodes	1,154	230	0.6%
CareLink Encore Programmer	Programmer, pacemaker	1,108	103	0%
CapSureFix Novus Lead MRI SureScan	Permanent pacemaker electrode	1,053	17,554	1%
SelectSecure MRI SureScan	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	962	4,994	1.3%
Sprint Fidelis	Implantable cardioverter defibrillator (non-crt)	871	340	14.1%
Carelink Smartsync Platform Ios	Analyzer, pacemaker generator function	855	1	0%
Sprint	Implantable cardioverter defibrillator (non-crt)	775	161	2.4%
Affera	Percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation	774	992	2.1%
Synchromed El	Pump, infusion, implanted, programmable	737	2	4.9%
Asku	Pulse-generator, pacemaker, external	711	210	1.1%
Transvene	Implantable cardioverter defibrillator (non-crt)	685	0	2%
MyCareLink Patient Monitor	Pulse generator, permanent, implantable	618	47	0.1%
Drug Eluting Permanent Left Ventricular Lv Pacemaker Electrode	Drug eluting permanent left ventricular (lv) pacemaker electrode	546	80	0.3%
Pacing System Analyzer	Programmer, pacemaker	545	92	0%
Indura	Pump, infusion, implanted, programmable	544	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
OSR	Pacemaker/icd/crt non-implanted components	56,126	36.1%
KRG	Programmer, pacemaker	20,667	13.3%
DTB	Permanent pacemaker electrode	12,694	8.2%
LWS	Implantable cardioverter defibrillator (non-crt)	12,522	8.1%
DXY	Implantable pacemaker pulse-generator	10,366	6.7%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	5,128	3.3%
DTE	Pulse-generator, pacemaker, external	4,861	3.1%
NVZ	Pulse generator, permanent, implantable	4,378	2.8%
DTC	Analyzer, pacemaker generator function	3,235	2.1%
LKK	Pump, infusion, implanted, programmable	2,918	1.9%

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

Death1.8%2,738

Injury22.6%35,136

Malfunction74.6%115,873

Other0.8%1,250

Not given0.3%421

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

Questions about Medtronic reports

How many FDA device reports name Medtronic as manufacturer?

155,418 reports through August 2026, 61,714 of them in the latest 12 months.

Which of its brands appear most often?

CareLink SmartSync Common App iOS (56,769), Carelink (12,832), Carelink Programmer (6,249), Dual Chamber Temporary Pacemaker (4,007) and Permanent Pacemaker Electrode (2,975).

Which device types does it report on?

pacemaker/icd/crt non-implanted components (36.1%), programmer, pacemaker (13.3%), permanent pacemaker electrode (8.2%) and implantable cardioverter defibrillator (non-crt) (8.1%).

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.