Device manufacturer, as written on reports

Medtronic Puerto Rico Villalba: medical device reports filed with FDA

46,144 reports name it as the manufacturer of the device involved, 2014–2026.

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.

46,144
reports naming it as manufacturer: 0.2% of all MAUDE reports; 38,174
reports, 12 months to August 2026: 7,140 in the 12 months before; 54.1%
classified as malfunction: 62.3% across all reports; 0.9%
classified as death, as reported: 0.9% across all reports

46,144 medical device reports received by FDA give Medtronic Puerto Rico Villalba as the manufacturer of the device involved, 0.2% of the MAUDE database, from February 2014 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

38,174 reports arrived in the 12 months to August 2026, up 435% from 7,140 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 (54.1%), injury (45%) and death (0.9%). 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	17,728	17,554	1%
Sprint Quattro Secure S MRI SureScan	Implantable cardioverter defibrillator (non-crt)	6,581	6,436	1.4%
SelectSecure MRI SureScan	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	5,450	4,994	1.3%
CapSureFix Novus MRI SureScan	Permanent pacemaker electrode	3,509	3,243	1.3%
Sprint Quattro Secure MRI SureScan	Implantable cardioverter defibrillator (non-crt)	2,246	1,903	1.4%
Epsila EV MRI SureScan	Permanent defibrillator electrodes	1,162	1,023	1%
CapSure Sense Lead MRI SureScan	Permanent pacemaker electrode	1,119	1,337	1%
Attain Stability Quad MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	968	837	1.3%
Attain Performa MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	743	647	1.4%
CapSure Fix MRI	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	724	600	0.6%
CapSure Epicardial Lead	Permanent pacemaker electrode	687	760	1.5%
Attain Performa S MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	532	440	1.6%
OmniaSecure MRI SureScan	Permanent defibrillator electrodes	456	462	1.1%
CapSureFix Lead	Permanent pacemaker electrode	415	358	0.8%
Sprint Fidelis	Implantable cardioverter defibrillator (non-crt)	397	340	14.1%
CapSure SP Novus Lead	Permanent pacemaker electrode	389	331	1.1%
CapSure Z Novus Lead	Permanent pacemaker electrode	341	313	0.4%
Attain Performa Straight MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	336	271	1.7%
Sensight	Stimulator, electrical, implanted, for parkinsonian tremor	229	250	1.6%
CapSure SP	Permanent pacemaker electrode	218	226	3.9%
Screw-In Lead	Permanent pacemaker electrode	188	163	0.6%
Attain Ability MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	177	162	0.3%
Arctic Front Advance Pro Cardiac Cryoablation Catheter	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	152	152	2.5%
Sprint	Implantable cardioverter defibrillator (non-crt)	143	161	2.4%
Sprint Quattro Lead	Implantable cardioverter defibrillator (non-crt)	135	104	1.3%
Attain Bipolar Over The Wire Lead	Implantable pulse generator, pacemaker (non-crt)	117	97	1.9%
Activa	Stimulator, electrical, implanted, for parkinsonian tremor	116	1,112	0.6%
Attain Ability Plus MRI SureScan	Drug eluting permanent left ventricular (lv) pacemaker electrode	110	88	1.4%
Arctic Front Advance Cardiac Cryoablation Catheter	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	46	46	2.6%
Attain Over The Wire Lead	Implantable pulse generator, pacemaker (non-crt)	33	51	2.4%

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	24,616	53.3%
LWS	Implantable cardioverter defibrillator (non-crt)	8,579	18.6%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	6,320	13.7%
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	2,949	6.4%
NVY	Permanent defibrillator electrodes	2,697	5.8%
MHY	Stimulator, electrical, implanted, for parkinsonian tremor	318	0.7%
OAE	Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation	213	0.5%
LWP	Implantable pulse generator, pacemaker (non-crt)	173	0.4%
LGW	Stimulator, spinal-cord, totally implanted for pain relief	89	0.2%
DRB	Stylet, catheter	31	0.1%

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

Death0.9%423

Injury45%20,762

Malfunction54.1%24,955

Other0%4

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 Puerto Rico Villalba reports

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

46,144 reports through August 2026, 38,174 of them in the latest 12 months.

Which of its brands appear most often?

CapSureFix Novus Lead MRI SureScan (17,728), Sprint Quattro Secure S MRI SureScan (6,581), SelectSecure MRI SureScan (5,450), CapSureFix Novus MRI SureScan (3,509) and Sprint Quattro Secure MRI SureScan (2,246).

Which device types does it report on?

permanent pacemaker electrode (53.3%), implantable cardioverter defibrillator (non-crt) (18.6%), drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes (13.7%) and drug eluting permanent left ventricular (lv) pacemaker electrode (6.4%).

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.