Devices › Drug eluting permanent left ventricular (lv) pacemaker electrode
Device brand name · Lv lead
Sentus ProMRI OTW QP S-85/49: medical device reports filed with FDA
627 reports name it, 2017–2026. Manufacturer given most often on reports: Biotronik Se & Kg. Product code OJX.
- 627
- device reports naming the brand
- 0% of all MAUDE reports · about 69 a year
- 50
- reports, 12 months to August 2026
- 65 in the 12 months before
- 71.3%
- classified as malfunction
- 40.2% across the product code
- 0.2%
- classified as death, as reported
- 1 reports · not verified by FDA
627 medical device reports received by FDA name the brand "Sentus ProMRI OTW QP S-85/49" (lv lead); the manufacturer given most often on reports is Biotronik Se & Kg; received from June 2017 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
50 reports arrived in the 12 months to August 2026, down 23% from 65 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 (71.3%), injury (28.5%) and death (0.2%); across all drug eluting permanent left ventricular (lv) pacemaker electrode reports (product code OJX) death is recorded in 3.5% and malfunction in 40.2%. 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 (59.2%), failure to capture (10%) and high impedance (7.2%). The patient problems coded most often are undesired nerve stimulation, muscle stimulation and twiddlers syndrome. 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 52,462 reports carrying product code OJX. 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 | 371 | 59.2% | 23.6% |
| Failure to capture | 63 | 10% | 15.6% |
| High impedance | 45 | 7.2% | 8.6% |
| Fracturea broken bone | 31 | 4.9% | 3% |
| Ambient noise problem | 26 | 4.1% | 0.5% |
| High capture threshold | 23 | 3.7% | 15.9% |
| Over-sensing | 15 | 2.4% | 1% |
| Impedance problem | 13 | 2.1% | 2.4% |
| Breakthe device broke | 10 | 1.6% | 2.3% |
| Extracardiac stimulation | 10 | 1.6% | 1.5% |
| Device sensing problem | 9 | 1.4% | 0.7% |
| Failure to sense | 6 | 1% | 0.3% |
| Insufficient device problem information | 6 | 1% | 2.2% |
| Pacing problem | 6 | 1% | 1% |
| Intermittent capture | 3 | 0.5% | 1.1% |
| Malposition of device | 3 | 0.5% | 0.1% |
| Positioning problem | 3 | 0.5% | 2.9% |
| Under-sensing | 2 | 0.3% | 0.2% |
| Activation, positioning or separation problem | 1 | 0.2% | 3% |
| Capturing problem | 1 | 0.2% | 5.4% |
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 |
|---|---|---|
| Undesired nerve stimulation | 14 | 2.2% |
| Muscle stimulation | 10 | 1.6% |
| Twiddlers syndrome | 8 | 1.3% |
| Pocket erosion | 6 | 1% |
| Vascular dissection | 6 | 1% |
| Endocarditis | 3 | 0.5% |
| Pericardial effusionfluid around the heart | 3 | 0.5% |
| Dizzinesslight-headedness or unsteadiness | 2 | 0.3% |
| Dyspneashortness of breath | 2 | 0.3% |
| Hematomaa collection of blood under the skin or in tissue | 2 | 0.3% |
| Bacteremia | 1 | 0.2% |
| Bacterial infectiona bacterial infection | 1 | 0.2% |
| Cardiac perforation | 1 | 0.2% |
| Cardiac tamponade | 1 | 0.2% |
| Deaththe patient died; cause not stated by this term | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Sentus ProMRI OTW QP S-85/49 | Product code OJX | All MAUDE reports |
|---|---|---|---|
| Reports | 627 | 52,462 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 2 | 35 | 9 |
| Classified as injury | 28.5% | 56.2% | 36.2% |
| Classified as malfunction | 71.3% | 40.2% | 62.3% |
| Filed by the manufacturer | 100% | 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 OJX
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Quartet | 14,149 | 848 | 5.2% |
| Attain Ability | 5,253 | 0 | 4.4% |
| Attain Performa MRI SureScan | 4,795 | 647 | 1.4% |
| Attain Stability Quad MRI SureScan | 4,176 | 837 | 1.3% |
| Attain Performa | 3,995 | 0 | 1.8% |
| Attain Performa S MRI SureScan | 3,158 | 440 | 1.6% |
| Quickflex Micro Lv Lead | 3,702 | 116 | 5.9% |
| Attain Performa Straight MRI SureScan | 2,065 | 271 | 1.7% |
| Easytrak 2 | 4,260 | 18 | 0.8% |
| Attain Ability Plus | 1,887 | 0 | 2.9% |
| Sentus ProMRI OTW QP L-85/49 | 1,684 | 249 | 0.5% |
| Acuity | 3,848 | 6 | 1% |
| Attain Ability MRI SureScan | 1,344 | 162 | 0.3% |
| Quartet Lead Double Bend, 86 cm | 1,207 | 91 | 2.6% |
| Drug Eluting Permanent Left Ventricular Lv Pacemaker Electrode | 1,234 | 80 | 0.3% |
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 Sentus ProMRI OTW QP S-85/49 reports
How many FDA reports name Sentus ProMRI OTW QP S-85/49?
627 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 50 in the latest 12 months.
What kinds of events are reported?
malfunction (71.3%), injury (28.5%) and death (0.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (59.2%), failure to capture (10%), high impedance (7.2%), fracture (4.9%) and ambient noise problem (4.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Sentus ProMRI OTW QP S-85/49 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.