Device manufacturer, as written on reports

Abbott Medical Crm-Sylmar: medical device reports filed with FDA

11,302 reports name it as the manufacturer of the device involved, 2026–2026.

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.

11,302
reports naming it as manufacturer: 0% of all MAUDE reports; 11,302
reports, 12 months to August 2026: 0 in the 12 months before; 57.7%
classified as malfunction: 62.3% across all reports; 2%
classified as death, as reported: 0.9% across all reports

11,302 medical device reports received by FDA give Abbott Medical Crm-Sylmar as the manufacturer of the device involved, 0% of the MAUDE database, from February 2026 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

11,302 reports arrived in the 12 months to August 2026, with none 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 (57.7%), injury (40.2%) and death (2%). 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
Tendril Sts	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	1,796	4,320	3.1%
Assurity Mri	Implantable pulse generator, pacemaker (non-crt)	884	2,035	1.8%
Gallant HF	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	809	1,918	0.7%
Durata Sts Optim Active Fixation Df-4 Connector	Permanent defibrillator electrodes	695	1,784	3.9%
Aveir Leadless Pacemaker, Right Ventricle	Leadless pacemaker	676	1,372	3.9%
Assert-IQ ICM	Recorder, event, implantable cardiac, (without arrhythmia detection)	541	1,162	0%
AVEIR AR 2 Leadless Pacemaker	Leadless pacemaker	401	519	1.3%
Quartet	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	355	848	5.2%
UltiPace Lead, 52cm MRI	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	344	673	1.8%
UltiPace Lead, 65cm MRI	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	272	638	0.7%
Optisure Active Fixation Df-4 Connector	Permanent defibrillator electrodes	260	623	4.3%
Aveir Delivery Catheter	Leadless pacemaker	239	433	11.8%
Quadra Assura MP ICD	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	200	507	2.1%
UltiPace Lead, 58cm MRI	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	191	427	1.2%
Tendril Sdx Lead	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	189	431	4.5%
Tendril St	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	188	547	5.2%
Tendril Mri	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	176	422	4.1%
Isoflex Optim Lead	Permanent defibrillator electrodes	174	437	2%
Durata Sts Optim Active Fixation	Implantable cardioverter defibrillator (non-crt)	131	301	5.6%
Aveir Leadless Pacemaker, Right Atrium	Leadless pacemaker	130	523	1.4%
Neutrino NxT HF	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	130	331	0.6%
UltiPace Lead, 46cm MRI	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	99	184	0.9%
Gallant VR	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	95	245	2%
Quadra Allure MP CRT-P	Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)	85	205	2.2%
Unify Assura CRT-D RF HV	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	75	186	3.7%
Fortify Assura VR ICD, US	Implantable cardioverter defibrillator (non-crt)	67	213	2.3%

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
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	3,417	30.2%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	2,424	21.4%
PNJ	Leadless pacemaker	1,481	13.1%
NVY	Permanent defibrillator electrodes	1,271	11.2%
LWP	Implantable pulse generator, pacemaker (non-crt)	1,007	8.9%
MXC	Recorder, event, implantable cardiac, (without arrhythmia detection)	593	5.2%
NVZ	Pulse generator, permanent, implantable	426	3.8%
LWS	Implantable cardioverter defibrillator (non-crt)	388	3.4%
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	102	0.9%
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)	90	0.8%

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

Death2%226

Injury40.2%4,540

Malfunction57.7%6,526

Other0.1%10

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 Abbott Medical Crm-Sylmar reports

How many FDA device reports name Abbott Medical Crm-Sylmar as manufacturer?

11,302 reports through August 2026, 11,302 of them in the latest 12 months.

Which of its brands appear most often?

Tendril Sts (1,796), Assurity Mri (884), Gallant HF (809), Durata Sts Optim Active Fixation Df-4 Connector (695) and Aveir Leadless Pacemaker, Right Ventricle (676).

Which device types does it report on?

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes (30.2%), defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) (21.4%), leadless pacemaker (13.1%) and permanent defibrillator electrodes (11.2%).

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.