Device manufacturer, as written on reports

Biotronik: medical device reports filed with FDA

3,795 reports name it as the manufacturer of the device involved, 1992–2026.

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.

3,795
reports naming it as manufacturer: 0% of all MAUDE reports; 1,067
reports, 12 months to August 2026: 345 in the 12 months before; 45.7%
classified as malfunction: 62.3% across all reports; 0.9%
classified as death, as reported: 0.9% across all reports

3,795 medical device reports received by FDA give Biotronik as the manufacturer of the device involved, 0% of the MAUDE database, from February 1992 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

1,067 reports arrived in the 12 months to August 2026, up 209% from 345 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 (45.7%), injury (37.9%) and other (15.4%). 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
Resilience 55	Stimulator, spinal-cord, totally implanted for pain relief	373	211	0%
Prospera IPG	Stimulator, spinal-cord, totally implanted for pain relief	235	127	0%
Belos Vr	Implantable cardioverter defibrillator (non-crt)	189	0	0.5%
Drug Eluting Permanent Right Ventricular Rv Or Right Atrial Ra Pacemaker Ele	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	144	405	0.3%
Permanent Defibrillator Electrodes	Permanent defibrillator electrodes	124	230	0.6%
Permanent Pacemaker Electrode	Permanent pacemaker electrode	93	332	0.4%
Implantable Cardioverter Defibrillator Non-Crt	Implantable cardioverter defibrillator (non-crt)	66	197	0.5%
Dextrus 4136	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	64	0	0.8%
Pulse Generator Permanent Implantable	Pulse generator, permanent, implantable	64	24	1.1%
Lead	Permanent pacemaker electrode	45	118	0.5%
Rv Lead	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	42	142	0.3%
Dextrus 4135	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	39	0	0.5%
Implantable Pacemaker Pulse-Generator	Implantable pacemaker pulse-generator	26	9	0.6%
Drug Eluting Permanent Left Ventricular Lv Pacemaker Electrode	Drug eluting permanent left ventricular (lv) pacemaker electrode	25	80	0.3%
Dextrus 4137	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	23	0	1%
Ra Lead	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	21	61	0.2%
Linox SD 65/16	Permanent defibrillator electrodes	19	31	1.2%
Atrial Lead	Permanent pacemaker electrode	17	13	1.2%
Setrox S 53	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	10	128	1.2%
Linox SD 65/18	Permanent defibrillator electrodes	9	24	1.1%
Lumax 340 Hf-T	Defibrillator, implantable, dual-chamber	9	0	9.7%
Lv Lead	Drug eluting permanent left ventricular (lv) pacemaker electrode	9	36	0.3%
Right Ventricular Lead	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	9	22	1.4%
Selox ST 53	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	7	16	0.7%
Setrox S 45	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	6	35	1.3%
Defibrillator Automatic Implantable Cardioverter With Cardiac Resynchronizatio	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	5	50	1%
Right Atrial Lead	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	5	10	0%
Linox Td 65/16	Permanent defibrillator electrodes	4	8	0.6%
Setrox S 60	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	4	43	0.6%
Linox Td 65/18	Permanent defibrillator electrodes	3	5	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
LGW	Stimulator, spinal-cord, totally implanted for pain relief	820	21.6%
NIQ	Coronary drug-eluting stent	477	12.6%
LWS	Implantable cardioverter defibrillator (non-crt)	473	12.5%
DTB	Permanent pacemaker electrode	415	10.9%
NVN	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	287	7.6%
NVY	Permanent defibrillator electrodes	274	7.2%
DXY	Implantable pacemaker pulse-generator	236	6.2%
MRM	Defibrillator, implantable, dual-chamber	148	3.9%
NVZ	Pulse generator, permanent, implantable	124	3.3%
LIT	Catheter, angioplasty, peripheral, transluminal	114	3%

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%33

Injury37.9%1,438

Malfunction45.7%1,733

Other15.4%584

Not given0.2%7

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

Questions about Biotronik reports

How many FDA device reports name Biotronik as manufacturer?

3,795 reports through August 2026, 1,067 of them in the latest 12 months.

Which of its brands appear most often?

Resilience 55 (373), Prospera IPG (235), Belos Vr (189), Drug Eluting Permanent Right Ventricular Rv Or Right Atrial Ra Pacemaker Ele (144) and Permanent Defibrillator Electrodes (124).

Which device types does it report on?

stimulator, spinal-cord, totally implanted for pain relief (21.6%), coronary drug-eluting stent (12.6%), implantable cardioverter defibrillator (non-crt) (12.5%) and permanent pacemaker electrode (10.9%).

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.