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FDA product code OJX · class 3 · Unknown
Drug eluting permanent left ventricular (lv) pacemaker electrode: medical device reports filed with FDA
52,462 reports carry this product code, 2005–2026; 30 brands with a page.
- 52,462
- reports with this product code
- 0.2% of all MAUDE reports
- 3,289
- reports, 12 months to August 2026
- 3,359 in the 12 months before
- 40.2%
- classified as malfunction
- 62.3% across all reports
- 3.5%
- classified as death, as reported
- 0.9% across all reports
Product code OJX is FDA's classification for "Drug eluting permanent left ventricular (lv) pacemaker electrode" (unknown panel), a class 3 device. 52,462 medical device reports carry this product code, 0.2% of the MAUDE database, from May 2005 to August 2026.
3,289 reports arrived in the 12 months to August 2026, close to the 3,359 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 injury (56.2%), malfunction (40.2%) and death (3.5%). 30 brand names with a page on this site carry this code; the brands table is 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."
Brands with this product code
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."
Manufacturers named
| Manufacturer (as written on reports) | Reports | Share |
|---|---|---|
| Mpri | 23,210 | 44.2% |
| St Jude Medical Crm-Sylmar | 5,848 | 11.1% |
| Cpi - Del Caribe | 4,344 | 8.3% |
| Biotronik Se & Kg | 3,939 | 7.5% |
| Medtronic Puerto Rico | 2,968 | 5.7% |
| Medtronic Puerto Rico Villalba | 2,949 | 5.6% |
| St Jude Medical Crmd | 2,042 | 3.9% |
| St Jude Medical Crm-Sunnyvale | 1,974 | 3.8% |
| St Jude Medical | 1,283 | 2.4% |
| Medtronic | 920 | 1.8% |
| St Jude Medical Cardiac Rhythm Management Division | 684 | 1.3% |
| St Jude Medical Crm-Kista | 442 | 0.8% |
| Abbott | 350 | 0.7% |
| Abbott Medical Crm-Sylmar | 102 | 0.2% |
| Rice Creek Mfg | 69 | 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 and report source
Event type
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Device dislodged or dislocated | 12,356 | 23.6% |
| High capture threshold | 8,330 | 15.9% |
| Failure to capture | 8,188 | 15.6% |
| High impedance | 4,523 | 8.6% |
| Capturing problem | 2,815 | 5.4% |
| Activation, positioning or separation problem | 1,578 | 3% |
| Fracturea broken bone | 1,553 | 3% |
| Positioning problem | 1,499 | 2.9% |
| Impedance problem | 1,275 | 2.4% |
| Low impedance | 1,220 | 2.3% |
| Breakthe device broke | 1,209 | 2.3% |
| Insufficient device problem information | 1,163 | 2.2% |
| Extracardiac stimulation | 783 | 1.5% |
| Unstable capture threshold | 694 | 1.3% |
| Difficult to position | 678 | 1.3% |
| Difficult to insertthe device was hard to insert | 570 | 1.1% |
| Intermittent capture | 556 | 1.1% |
| Over-sensing | 533 | 1% |
| Pacing problem | 533 | 1% |
| Material integrity problema problem with the device material | 507 | 1% |
Questions about drug eluting permanent left ventricular (lv) pacemaker electrode reports
What is product code OJX?
FDA's classification code for "Drug eluting permanent left ventricular (lv) pacemaker electrode", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
52,462 reports through August 2026, 3,289 of them in the latest 12 months.
Which brands appear most often?
Quartet (5,726), Attain Ability (5,251), Attain Performa MRI SureScan (4,794), Attain Stability Quad MRI SureScan (4,176) and Attain Performa (3,993). Widely used products collect more reports because more people use them.
Can the brands table be used to rank the devices?
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." Brands differ in how many are in use, how long they have been sold and how reports are collected.
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. 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.