Device manufacturer, as written on reports

Mpri: medical device reports filed with FDA

293,091 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.

293,091
reports naming it as manufacturer: 1.1% of all MAUDE reports; 0
reports, 12 months to August 2026: 28,636 in the 12 months before; 41.7%
classified as malfunction: 62.3% across all reports; 1.8%
classified as death, as reported: 0.9% across all reports

293,091 medical device reports received by FDA give Mpri as the manufacturer of the device involved, 1.1% of the MAUDE database, from May 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 28,636 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 (56.4%), malfunction (41.7%) 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
CapSureFix Novus Lead MRI SureScan	Permanent pacemaker electrode	72,790	17,554	1%
Capsurefix Novus	Permanent pacemaker electrode	37,142	4	6.8%
Sprint Quattro Secure S MRI SureScan	Implantable cardioverter defibrillator (non-crt)	24,513	6,436	1.4%
SelectSecure MRI SureScan	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	14,405	4,994	1.3%
Sprint Quattro Secure	Implantable cardioverter defibrillator (non-crt)	13,809	2	5.2%
CapSureFix Novus MRI SureScan	Permanent pacemaker electrode	13,601	3,243	1.3%
Sprint Quattro Secure MRI SureScan	Implantable cardioverter defibrillator (non-crt)	12,553	1,903	1.4%
Sprint Quattro Secure S	Implantable cardioverter defibrillator (non-crt)	11,289	0	2.4%
Sprint Fidelis	Implantable cardioverter defibrillator (non-crt)	6,938	340	14.1%
CapSure Fix MRI	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	4,622	600	0.6%
CapSure Sense Lead MRI SureScan	Permanent pacemaker electrode	4,578	1,337	1%
Capsurefix Mri Surescan	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	3,994	0	2.8%
Attain Performa	Drug eluting permanent left ventricular (lv) pacemaker electrode	3,960	0	1.8%
Attain Performa MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	3,919	647	1.4%
CapSure SP	Permanent pacemaker electrode	3,587	226	3.9%
Capsurefix	Permanent pacemaker electrode	3,434	0	6.3%
Sprint Quattro	Implantable cardioverter defibrillator (non-crt)	3,141	0	2.6%
Attain Otw	Permanent pacemaker electrode	3,129	0	9.1%
Attain Stability Quad MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	3,037	837	1.3%
Attain Performa S MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	2,576	440	1.6%
CapSure Epicardial Lead	Permanent pacemaker electrode	2,496	760	1.5%
Attain Ability	Drug eluting permanent left ventricular (lv) pacemaker electrode	2,443	0	4.4%
Capsure Sp Novus	Permanent pacemaker electrode	2,409	0	9.5%
Selectsecure	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	2,405	0	0.9%
CapSureFix Lead	Permanent pacemaker electrode	2,372	358	0.8%
Capsure Sense	Permanent pacemaker electrode	2,333	0	6.4%
CapSure SP Novus Lead	Permanent pacemaker electrode	2,169	331	1.1%
Sprint	Implantable cardioverter defibrillator (non-crt)	2,063	161	2.4%
CapSure Z Novus Lead	Permanent pacemaker electrode	1,735	313	0.4%
Attain Performa Straight MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	1,686	271	1.7%

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
DTB	Permanent pacemaker electrode	154,752	52.8%
LWS	Implantable cardioverter defibrillator (non-crt)	67,400	23%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	28,511	9.7%
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	23,210	7.9%
NVY	Permanent defibrillator electrodes	10,416	3.6%
LWP	Implantable pulse generator, pacemaker (non-crt)	4,875	1.7%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	1,294	0.4%
LGW	Stimulator, spinal-cord, totally implanted for pain relief	833	0.3%
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	578	0.2%
EZW	Stimulator, electrical, implantable, for incontinence	450	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

Death1.8%5,419

Injury56.4%165,436

Malfunction41.7%122,235

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 Mpri reports

How many FDA device reports name Mpri as manufacturer?

293,091 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

CapSureFix Novus Lead MRI SureScan (72,790), Capsurefix Novus (37,142), Sprint Quattro Secure S MRI SureScan (24,513), SelectSecure MRI SureScan (14,405) and Sprint Quattro Secure (13,809).

Which device types does it report on?

permanent pacemaker electrode (52.8%), implantable cardioverter defibrillator (non-crt) (23%), drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes (9.7%) and drug eluting permanent left ventricular (lv) pacemaker electrode (7.9%).

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.