Device manufacturer, as written on reports

Biotronik And: medical device reports filed with FDA

3,418 reports name it as the manufacturer of the device involved, 2004–2009.

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.

3,418
reports naming it as manufacturer: 0% of all MAUDE reports; 0
reports, 12 months to August 2026: 0 in the 12 months before; 20.7%
classified as malfunction: 62.3% across all reports; 2.5%
classified as death, as reported: 0.9% across all reports

3,418 medical device reports received by FDA give Biotronik And as the manufacturer of the device involved, 0% of the MAUDE database, from November 2004 to August 2009. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

0 reports arrived in the 12 months to August 2026, and 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 injury (68.5%), malfunction (20.7%) and other (7.4%). 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
Dextrus 4136	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	654	0	0.8%
Dextrus 4135	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	370	0	0.5%
Setrox S 53	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	213	128	1.2%
Dextrus 4137	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	208	0	1%
Setrox S 45	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	165	35	1.3%
Linox SD 65/16	Permanent defibrillator electrodes	130	31	1.2%
Linox SD 65/18	Permanent defibrillator electrodes	64	24	1.1%
Selox ST 53	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	56	16	0.7%
Selox St 60	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	45	6	0.6%
Lumax 340 Vr-T	Implantable cardioverter defibrillator (non-crt)	42	0	5.2%
Lumax 340 Hf-T	Defibrillator, implantable, dual-chamber	40	0	9.7%
Setrox S 60	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	40	43	0.6%
Selox Jt 45	Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes	32	12	0.7%
Linox S 65	Permanent defibrillator electrodes	19	25	0.6%
Linox Td 65/16	Permanent defibrillator electrodes	16	8	0.6%
Linox Td 65/18	Permanent defibrillator electrodes	12	5	0.6%
Belos Vr	Implantable cardioverter defibrillator (non-crt)	5	0	0.5%

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	2,124	62.1%
LWS	Implantable cardioverter defibrillator (non-crt)	667	19.5%
DXY	Implantable pacemaker pulse-generator	405	11.8%
MRM	Defibrillator, implantable, dual-chamber	151	4.4%
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (crt-p)	23	0.7%
NVZ	Pulse generator, permanent, implantable	10	0.3%
DQX	Wire, guide, catheter	9	0.3%
NIK	Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)	9	0.3%
DTE	Pulse-generator, pacemaker, external	5	0.1%
KRG	Programmer, pacemaker	5	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

Death2.5%85

Injury68.5%2,341

Malfunction20.7%709

Other7.4%254

Not given0.8%29

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

Questions about Biotronik And reports

How many FDA device reports name Biotronik And as manufacturer?

3,418 reports through August 2026, 0 of them in the latest 12 months.

Which of its brands appear most often?

Dextrus 4136 (654), Dextrus 4135 (370), Setrox S 53 (213), Dextrus 4137 (208) and Setrox S 45 (165).

Which device types does it report on?

permanent pacemaker electrode (62.1%), implantable cardioverter defibrillator (non-crt) (19.5%), implantable pacemaker pulse-generator (11.8%) and defibrillator, implantable, dual-chamber (4.4%).

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.