Devices › Permanent defibrillator electrodes
Device brand name · Permanent pacemaker electrode
Isoflex Optim Lead: medical device reports filed with FDA
7,889 reports name it, 2009–2026. Manufacturer given most often on reports: St Jude Medical Crm-Sylmar. Product code NVY.
- 7,889
- device reports naming the brand
- 0% of all MAUDE reports · about 455 a year
- 437
- reports, 12 months to August 2026
- 579 in the 12 months before
- 51.8%
- classified as malfunction
- 41.2% across the product code
- 2%
- classified as death, as reported
- 155 reports · not verified by FDA
7,889 medical device reports received by FDA name the brand "Isoflex Optim Lead" (permanent pacemaker electrode); the manufacturer given most often on reports is St Jude Medical Crm-Sylmar; received from March 2009 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
437 reports arrived in the 12 months to August 2026, down 25% from 579 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 (51.8%), injury (46.3%) and death (2%); across all permanent defibrillator electrodes reports (product code NVY) death is recorded in 2.2% and malfunction in 41.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are over-sensing (27.2%), device dislodged or dislocated (16.1%) and failure to capture (15.9%). The patient problems coded most often are dizziness, death and discomfort. 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 138,578 reports carrying product code NVY. 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 |
|---|---|---|---|
| Over-sensing | 2,142 | 27.2% | 22.8% |
| Device dislodged or dislocated | 1,269 | 16.1% | 10.9% |
| Failure to capture | 1,254 | 15.9% | 8.1% |
| Signal artifact/noise | 1,101 | 14% | 6.6% |
| Breakthe device broke | 952 | 12.1% | 8.8% |
| High impedance | 681 | 8.6% | 20% |
| High capture threshold | 602 | 7.6% | 8.1% |
| Capturing problem | 472 | 6% | 3.7% |
| Failure to sense | 448 | 5.7% | 0.9% |
| Device sensing problem | 345 | 4.4% | 5% |
| Low impedance | 304 | 3.9% | 6% |
| Pacing problem | 291 | 3.7% | 2.1% |
| Fracturea broken bone | 289 | 3.7% | 5.4% |
| Under-sensing | 178 | 2.3% | 2.5% |
| Intermittent capture | 156 | 2% | 0.6% |
| Difficult to insertthe device was hard to insert | 140 | 1.8% | 0.2% |
| High sensing threshold | 111 | 1.4% | 0.3% |
| Impedance problem | 74 | 0.9% | 3.1% |
| Defective devicethe device was defective | 67 | 0.8% | 0.8% |
| Insufficient device problem information | 64 | 0.8% | 2.1% |
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 |
|---|---|---|
| Dizzinesslight-headedness or unsteadiness | 174 | 2.2% |
| Deaththe patient died; cause not stated by this term | 133 | 1.7% |
| Discomfortdiscomfort | 98 | 1.2% |
| Syncopefainting | 83 | 1.1% |
| Muscle stimulation | 75 | 1% |
| Arrhythmia | 61 | 0.8% |
| Syncope/fainting | 45 | 0.6% |
| Cardiac perforation | 35 | 0.4% |
| Undesired nerve stimulation | 35 | 0.4% |
| Bradycardiaslow heart rate | 32 | 0.4% |
| Fatiguetiredness | 31 | 0.4% |
| Twiddlers syndrome | 28 | 0.4% |
| Pocket erosion | 27 | 0.3% |
| Perforation | 22 | 0.3% |
| Cardiac arrestthe heart stopped | 21 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Isoflex Optim Lead | Product code NVY | All MAUDE reports |
|---|---|---|---|
| Reports | 7,889 | 138,578 | 26,136,888 |
| Share of that pool | — | 5.7% | 0% |
| Classified as death, per 1,000 reports | 20 | 22 | 9 |
| Classified as injury | 46.3% | 56.5% | 36.2% |
| Classified as malfunction | 51.8% | 41.2% | 62.3% |
| Filed by the manufacturer | 100% | 97.3% | 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 NVY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Durata Sts Optim Active Fixation Df-4 Connector | 27,828 | 1,784 | 3.9% |
| Endotak Reliance | 25,897 | 238 | 1.2% |
| Riata Active Fixation | 13,753 | 96 | 1.8% |
| Sprint Quattro Secure MRI SureScan | 15,606 | 1,903 | 1.4% |
| Optisure Active Fixation Df-4 Connector | 6,562 | 623 | 4.3% |
| Endotak Reliance Sg | 8,288 | 1,083 | 0.5% |
| Sprint Quattro Secure | 24,237 | 2 | 5.2% |
| Riata St Active Fixation | 5,416 | 76 | 2.2% |
| Reliance 4-Front | 9,852 | 2,024 | 0.4% |
| Durata Sts Optim Active Fixation | 9,681 | 301 | 5.6% |
| Riata Passive Fixation | 4,318 | 32 | 1.2% |
| Endotak Reliance G | 10,115 | 1,049 | 0.6% |
| Plexa ProMRI S 65 | 2,521 | 245 | 0.6% |
| Permanent Defibrillator Electrodes | 2,524 | 230 | 0.6% |
| Epsila EV MRI SureScan | 1,869 | 1,023 | 1% |
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 Isoflex Optim Lead reports
How many FDA reports name Isoflex Optim Lead?
7,889 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 437 in the latest 12 months.
What kinds of events are reported?
malfunction (51.8%), injury (46.3%) and death (2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
over-sensing (27.2%), device dislodged or dislocated (16.1%), failure to capture (15.9%), signal artifact/noise (14%) and break (12.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Isoflex Optim Lead 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.