Device manufacturer, as written on reports

Biotronik Se & Kg: medical device reports filed with FDA

76,593 reports name it as the manufacturer of the device involved, 2009–2026.

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.

76,593
reports naming it as manufacturer: 0.3% of all MAUDE reports; 6,233
reports, 12 months to August 2026: 6,204 in the 12 months before; 56.7%
classified as malfunction: 62.3% across all reports; 0.9%
classified as death, as reported: 0.9% across all reports

76,593 medical device reports received by FDA give Biotronik Se & Kg as the manufacturer of the device involved, 0.3% of the MAUDE database, from July 2009 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

6,233 reports arrived in the 12 months to August 2026, close to the 6,204 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 (56.7%), injury (41.9%) 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
Solia S 53	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	4,993	647	0.5%
Dextrus 4136	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	4,910	0	0.8%
Setrox S 53	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	3,309	128	1.2%
Solia S 60	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	2,637	495	0.5%
Plexa ProMRI S 65	Permanent defibrillator electrodes	2,519	245	0.6%
Dextrus 4135	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	2,298	0	0.5%
Solia S 45	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	2,021	241	0.5%
Dextrus 4137	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	2,017	0	1%
Dextrus 53 Model 4136 US 644136-102	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	1,821	155	0.4%
Sentus ProMRI OTW QP L-85/49	Drug eluting permanent left ventricular (lv) pacemaker electrode	1,684	249	0.5%
Linox Smart S DX 65/15	Permanent defibrillator electrodes	1,184	113	0.5%
Protego ProMRI S 65	Permanent defibrillator electrodes	1,088	76	0.6%
Setrox S 60	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	1,052	43	0.6%
Setrox S 45	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	986	35	1.3%
Linox SD 65/16	Permanent defibrillator electrodes	969	31	1.2%
Linox S 65	Permanent defibrillator electrodes	901	25	0.6%
Plexa ProMRI S DX 65/15	Permanent defibrillator electrodes	889	130	0.1%
Dextrus 60 Model 4137 US 644137-102	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	860	49	0.5%
Dextrus 45 Model 4135 US 644135-102	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	831	82	0.4%
Plexa ProMRI DF-1 S DX 65/15	Permanent defibrillator electrodes	820	93	0%
Linox SD 65/18	Permanent defibrillator electrodes	792	24	1.1%
Protego S 65	Permanent defibrillator electrodes	619	44	1.2%
Linox Smart S 65	Permanent defibrillator electrodes	618	26	0.7%
Linox Smart S DX 65/17	Permanent defibrillator electrodes	614	45	0.2%
Sentus ProMRI OTW QP S-85/49	Drug eluting permanent left ventricular (lv) pacemaker electrode	609	50	0.2%
Acticor 7 VR-T DX DF4 ProMRI	Implantable cardioverter defibrillator (non-crt)	582	180	1%
Linox Smart ProMRI S 65	Permanent defibrillator electrodes	534	20	0.2%
Selox ST 53	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	533	16	0.7%
Linox Smart SD 65/18	Permanent defibrillator electrodes	532	22	0.4%
BIOMONITOR IIIm	Recorder, event, implantable cardiac, (with arrhythmia detection)	391	66	0%

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	26,700	34.9%
NVY	Permanent defibrillator electrodes	18,984	24.8%
LWS	Implantable cardioverter defibrillator (non-crt)	7,950	10.4%
NVZ	Pulse generator, permanent, implantable	7,245	9.5%
MRM	Defibrillator, implantable, dual-chamber	4,151	5.4%
OJX	Drug eluting permanent left ventricular (lv) pacemaker electrode	3,939	5.1%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	2,651	3.5%
DTB	Permanent pacemaker electrode	2,100	2.7%
MXD	Recorder, event, implantable cardiac, (with arrhythmia detection)	1,486	1.9%
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)	611	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

Death0.9%726

Injury41.9%32,109

Malfunction56.7%43,416

Other0.3%251

Not given0.1%91

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

Questions about Biotronik Se & Kg reports

How many FDA device reports name Biotronik Se & Kg as manufacturer?

76,593 reports through August 2026, 6,233 of them in the latest 12 months.

Which of its brands appear most often?

Solia S 53 (4,993), Dextrus 4136 (4,910), Setrox S 53 (3,309), Solia S 60 (2,637) and Plexa ProMRI S 65 (2,519).

Which device types does it report on?

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes (34.9%), permanent defibrillator electrodes (24.8%), implantable cardioverter defibrillator (non-crt) (10.4%) and pulse generator, permanent, implantable (9.5%).

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.