Devices › Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Device brand name · Pacer lead
Setrox S 53: medical device reports filed with FDA
3,552 reports name it, 2006–2026. Manufacturer given most often on reports: Biotronik Se & Kg. Product code NVN.
- 3,552
- device reports naming the brand
- 0% of all MAUDE reports · about 176 a year
- 128
- reports, 12 months to August 2026
- 143 in the 12 months before
- 47.5%
- classified as malfunction
- 41.6% across the product code
- 1.2%
- classified as death, as reported
- 42 reports · not verified by FDA
FDA's MAUDE database holds 3,552 reports that name the brand "Setrox S 53" (pacer lead), received between May 2006 and August 2026; the manufacturer given most often on reports is Biotronik Se & Kg. Spellings of one product vary from report to report.
128 reports arrived in the 12 months to August 2026, down 10% from 143 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 (50.6%), malfunction (47.5%) and death (1.2%); across all drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes reports (product code NVN) death is recorded in 2.2% and malfunction in 41.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device dislodged or dislocated (20.1%), ambient noise problem (12.5%) and failure to capture (11.1%). The patient problems coded most often are surgical procedure, twiddlers syndrome and death. 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."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 229,796 reports carrying product code NVN. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Device dislodged or dislocated | 714 | 20.1% | 15.8% |
| Ambient noise problem | 445 | 12.5% | 1.4% |
| Failure to capture | 396 | 11.1% | 12.6% |
| High capture threshold | 324 | 9.1% | 10.7% |
| High impedance | 189 | 5.3% | 9.1% |
| Fracturea broken bone | 178 | 5% | 4.7% |
| Insufficient device problem information | 150 | 4.2% | 2.6% |
| Normal | 142 | 4% | 0% |
| Over-sensing | 120 | 3.4% | 17.9% |
| Under-sensing | 102 | 2.9% | 4.5% |
| Dislodged | 89 | 2.5% | 0% |
| Breakthe device broke | 88 | 2.5% | 5.2% |
| Impedance problem | 86 | 2.4% | 2.2% |
| Low impedance | 68 | 1.9% | 5.1% |
| Explanted | 64 | 1.8% | 0% |
| Device sensing problem | 60 | 1.7% | 3.7% |
| Intermittent capture | 58 | 1.6% | 1.1% |
| Failure to sense | 53 | 1.5% | 2% |
| High sensing threshold | 35 | 1% | 0.5% |
| Pacing problem | 28 | 0.8% | 4.4% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Surgical procedure | 184 | 5.2% |
| Twiddlers syndrome | 45 | 1.3% |
| Deaththe patient died; cause not stated by this term | 41 | 1.2% |
| Pocket erosion | 38 | 1.1% |
| Cardiac perforation | 33 | 0.9% |
| Painpain, site not specified | 33 | 0.9% |
| Endocarditis | 30 | 0.8% |
| Sepsisa severe body-wide response to infection | 29 | 0.8% |
| Shock from patient lead(s) | 28 | 0.8% |
| Staphylococcus aureus | 17 | 0.5% |
| Discomfortdiscomfort | 12 | 0.3% |
| Muscle stimulation | 12 | 0.3% |
| Bacterial infectiona bacterial infection | 11 | 0.3% |
| Cardiac arrestthe heart stopped | 11 | 0.3% |
| Falla fall | 11 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Setrox S 53 | Product code NVN | All MAUDE reports |
|---|---|---|---|
| Reports | 3,552 | 229,796 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 12 | 22 | 9 |
| Classified as injury | 50.6% | 56.2% | 36.2% |
| Classified as malfunction | 47.5% | 41.6% | 62.3% |
| Filed by the manufacturer | 99.7% | 96.9% | 94.9% |
Shares are of reports, not 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."
Other brands with product code NVN
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Tendril Sts | 54,036 | 4,320 | 3.1% |
| SelectSecure MRI SureScan | 20,961 | 4,994 | 1.3% |
| Tendril St | 20,156 | 547 | 5.2% |
| Ingevity Mri | 17,101 | 1,749 | 0.3% |
| Ingevity+ | 15,340 | 2,150 | 0.3% |
| Tendril Sdx Lead | 9,380 | 431 | 4.5% |
| CapSure Fix MRI | 5,755 | 600 | 0.6% |
| Solia S 53 | 4,997 | 647 | 0.5% |
| Tendril Mri | 7,076 | 422 | 4.1% |
| Drug Eluting Permanent Right Ventricular Rv Or Right Atrial Ra Pacemaker Ele | 4,462 | 405 | 0.3% |
| Capsurefix Mri Surescan | 4,247 | 0 | 2.8% |
| Tendril Sdx | 8,316 | 3 | 2.3% |
| Ingevity | 9,039 | 299 | 0.9% |
| Ingevity + | 3,053 | 2,281 | 0.6% |
| Dextrus 4136 | 5,698 | 0 | 0.8% |
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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Setrox S 53 reports
How many FDA reports name Setrox S 53?
3,552 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 128 in the latest 12 months.
What kinds of events are reported?
injury (50.6%), malfunction (47.5%) and death (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (20.1%), ambient noise problem (12.5%), failure to capture (11.1%), high capture threshold (9.1%) and high impedance (5.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and voluntary reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Setrox S 53 was at fault?
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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.