Implantable cardioverter defibrillator (non-crt): medical device reports filed with FDA

380,959 reports carry this product code, 1992–2026; 30 brands with a page.

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.

380,959
reports with this product code: 1.5% of all MAUDE reports; 23,653
reports, 12 months to August 2026: 24,744 in the 12 months before; 37.4%
classified as malfunction: 62.3% across all reports; 2.7%
classified as death, as reported: 0.9% across all reports

Product code LWS is FDA's classification for "Implantable cardioverter defibrillator (non-crt)" (unknown panel), a class 3 device. 380,959 medical device reports carry this product code, 1.5% of the MAUDE database, from July 1992 to August 2026.

23,653 reports arrived in the 12 months to August 2026, close to the 24,744 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 injury (59.6%), malfunction (37.4%) and death (2.7%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Sprint Quattro Secure S MRI SureScan	36,889	6,436	1.4%	41.5%
Emblem Mri S-Icd	21,479	3,088	0.2%	29.8%
Sprint Quattro Secure	19,549	2	5.2%	31.7%
Emblem S-Icd	17,246	2,237	0.1%	23.9%
Sprint Fidelis	16,993	340	14.1%	12.3%
Sprint Quattro Secure S	14,395	0	2.4%	38.1%
Endotak Reliance	9,853	238	1.2%	30.7%
Sprint Quattro Secure MRI SureScan	8,716	1,903	1.4%	39.9%
Endotak Reliance G	7,334	1,049	0.6%	39.1%
Teligen	6,438	47	0.6%	36.7%
Durata Sts Optim Active Fixation	5,732	301	5.6%	33.6%
Sprint Quattro	5,578	0	2.6%	23.1%
Reliance 4-Front	5,491	2,024	0.4%	35.1%
Sprint	5,479	161	2.4%	18.3%
Vitality 2	4,379	0	1%	61.4%
S-Icd System	4,327	0	1.1%	30.3%
Fortify Assura VR ICD, US	4,218	213	2.3%	32.2%
Implantable Cardioverter Defibrillator Non-Crt	3,063	197	0.5%	76.9%
Visia AF MRI XT VR SureScan	2,372	325	1.6%	23.8%
Transvene	2,225	0	2%	7.1%
Endotak Reliance Sg	2,180	1,083	0.5%	43.1%
Riata Active Fixation	2,088	96	1.8%	46.8%
Vitality	1,901	0	0.9%	64.1%
Energen	1,851	0	0.6%	41.2%
Incepta	1,764	0	0.7%	39%
Quadra Assura MP ICD	1,728	507	2.1%	72.1%
Virtuoso Vr	1,516	0	4.7%	13.9%
Autogen	1,483	212	1%	52.2%
Evera Xt Vr	1,474	91	4.1%	33.6%
Endotak Dsp	1,400	14	1.6%	59.9%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Boston Scientific	71,350	18.7%
Mpri	67,400	17.7%
Guidant Crm Clonmel Ireland	29,666	7.8%
Cardiac Pacemakers	26,151	6.9%
Medtronic Puerto Rico	24,308	6.4%
St Jude Medical Crmd	14,251	3.7%
Medtronic	12,522	3.3%
Medtronic Europe Sarl	12,356	3.2%
Cpi - Del Caribe	11,749	3.1%
St Jude Medical Crm-Sylmar	9,912	2.6%
St Jude Medical Crm-Sunnyvale	9,580	2.5%
Medtronic Med Rel	9,332	2.4%
St Jude Medical Cardiac Rhythm Management Division	9,125	2.4%
Medtronic Puerto Rico Villalba	8,579	2.3%
Medtronic Med Rel Medtronic Puerto Rico	8,109	2.1%

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 and report source

Event type

Death2.7%10,102

Injury59.6%227,220

Malfunction37.4%142,319

Other0.2%646

Not given0.2%672

Who filed

Manufacturer report97.8%372,586

Voluntary report1.5%5,801

User facility report0%0

Distributor report0.1%331

Not given0.6%2,241

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Over-sensing	80,485	21.1%
High impedance	59,567	15.6%
Inappropriate/inadequate shock/stimulation	48,817	12.8%
Premature discharge of battery	30,899	8.1%
Signal artifact/noise	30,329	8%
Fracturea broken bone	22,183	5.8%
Impedance problem	16,747	4.4%
Device sensing problem	14,736	3.9%
Pacing problem	14,442	3.8%
High capture threshold	13,694	3.6%
Under-sensing	11,766	3.1%
Low impedance	10,788	2.8%
Failure to capture	9,967	2.6%
Low battery	9,603	2.5%
Incorrect, inadequate or imprecise result or readings	8,797	2.3%
Failure to read input signal	8,029	2.1%
Battery problema problem with the battery	7,767	2%
Normal	7,046	1.8%
Device dislodged or dislocated	6,885	1.8%
Premature elective replacement indicator	6,615	1.7%

Questions about implantable cardioverter defibrillator (non-crt) reports

What is product code LWS?

FDA's classification code for "Implantable cardioverter defibrillator (non-crt)", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

380,959 reports through August 2026, 23,653 of them in the latest 12 months.

Which brands appear most often?

Sprint Quattro Secure S MRI SureScan (36,889), Emblem Mri S-Icd (21,479), Sprint Quattro Secure (19,549), Emblem S-Icd (17,246) and Sprint Fidelis (16,993). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.