Device manufacturer, as written on reports

Medtronic Singapore Operations: medical device reports filed with FDA

59,588 reports name it as the manufacturer of the device involved, 2011–2026.

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.

59,588
reports naming it as manufacturer: 0.2% of all MAUDE reports; 9,828
reports, 12 months to August 2026: 9,856 in the 12 months before; 62.1%
classified as malfunction: 62.3% across all reports; 1.4%
classified as death, as reported: 0.9% across all reports

59,588 medical device reports received by FDA give Medtronic Singapore Operations as the manufacturer of the device involved, 0.2% of the MAUDE database, from August 2011 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

9,828 reports arrived in the 12 months to August 2026, close to the 9,856 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 (62.1%), injury (36.4%) 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
CapSureFix Novus Lead MRI SureScan	Permanent pacemaker electrode	16,195	17,554	1%
Sprint Quattro Secure S MRI SureScan	Implantable cardioverter defibrillator (non-crt)	5,362	6,436	1.4%
Capsurefix Novus	Permanent pacemaker electrode	3,977	4	6.8%
CapSure Sense Lead MRI SureScan	Permanent pacemaker electrode	2,907	1,337	1%
Reveal LINQ	Detector and alarm, arrhythmia	1,921	264	0%
CapSureFix Novus MRI SureScan	Permanent pacemaker electrode	1,355	3,243	1.3%
Sprint Quattro Secure S	Implantable cardioverter defibrillator (non-crt)	988	0	2.4%
Capsure Sense	Permanent pacemaker electrode	973	0	6.4%
Adapta	Pulse generator, permanent, implantable	741	279	7.4%
Sensia IPG	Pulse generator, permanent, implantable	619	73	2.7%
Sprint Quattro Secure MRI SureScan	Implantable cardioverter defibrillator (non-crt)	305	1,903	1.4%
CapSure Fix MRI	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	281	600	0.6%
Relia IPG	Pulse generator, permanent, implantable	270	20	0.6%
Capsurefix Mri Surescan	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	198	0	2.8%
Advisa MRI SureScan	Pulse generator, permanent, implantable	157	272	1.9%
Sprint Quattro Secure	Implantable cardioverter defibrillator (non-crt)	106	2	5.2%
Versa Ipg	Pulse generator, permanent, implantable	82	12	8.1%
Relia S	Pulse generator, permanent, implantable	55	0	3.2%
Attain Ability	Drug eluting permanent left ventricular (lv) pacemaker electrode	19	0	4.4%
Attain Ability Plus	Drug eluting permanent left ventricular (lv) pacemaker electrode	16	0	2.9%
SelectSecure MRI SureScan	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	8	4,994	1.3%
Attain Ability Straight	Drug eluting permanent left ventricular (lv) pacemaker electrode	6	0	1.5%
Capsurefix Novus Mri	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	6	0	2.9%
CapSure Epicardial Lead	Permanent pacemaker electrode	4	760	1.5%
Capsure Sp Novus	Permanent pacemaker electrode	1	0	9.5%
Tbd	Catheter and tip, suction	1	8	0.6%

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	25,562	42.9%
NVZ	Pulse generator, permanent, implantable	14,454	24.3%
MXD	Recorder, event, implantable cardiac, (with arrhythmia detection)	10,170	17.1%
LWS	Implantable cardioverter defibrillator (non-crt)	6,361	10.7%
DSI	Detector and alarm, arrhythmia	1,930	3.2%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	523	0.9%
NVY	Permanent defibrillator electrodes	407	0.7%
DXY	Implantable pacemaker pulse-generator	172	0.3%
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	61	0.1%
DTE	Pulse-generator, pacemaker, external	2	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

Death1.4%862

Injury36.4%21,714

Malfunction62.1%37,012

Other0%0

Not given0%0

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

Questions about Medtronic Singapore Operations reports

How many FDA device reports name Medtronic Singapore Operations as manufacturer?

59,588 reports through August 2026, 9,828 of them in the latest 12 months.

Which of its brands appear most often?

CapSureFix Novus Lead MRI SureScan (16,195), Sprint Quattro Secure S MRI SureScan (5,362), Capsurefix Novus (3,977), CapSure Sense Lead MRI SureScan (2,907) and Reveal LINQ (1,921).

Which device types does it report on?

permanent pacemaker electrode (42.9%), pulse generator, permanent, implantable (24.3%), recorder, event, implantable cardiac, (with arrhythmia detection) (17.1%) and implantable cardioverter defibrillator (non-crt) (10.7%).

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.