Devices › Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
Device brand name · Permanent pacemaker electrode
Isoflex S Lead: medical device reports filed with FDA
1,620 reports name it, 2015–2026. Manufacturer given most often on reports: St Jude Medical Crm-Sylmar. Product code NVN.
- 1,620
- device reports naming the brand
- 0% of all MAUDE reports · about 145 a year
- 64
- reports, 12 months to August 2026
- 84 in the 12 months before
- 47.2%
- classified as malfunction
- 41.6% across the product code
- 4.4%
- classified as death, as reported
- 71 reports · not verified by FDA
1,620 medical device reports received by FDA name the brand "Isoflex S Lead" (permanent pacemaker electrode); the manufacturer given most often on reports is St Jude Medical Crm-Sylmar; received from May 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
64 reports arrived in the 12 months to August 2026, down 24% from 84 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 (48.4%), malfunction (47.2%) and death (4.4%); 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 over-sensing (27.3%), signal artifact/noise (15%) and high impedance (14.8%). The patient problems coded most often are death, dizziness and syncope. 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 |
|---|---|---|---|
| Over-sensing | 442 | 27.3% | 17.9% |
| Signal artifact/noise | 243 | 15% | 9% |
| High impedance | 239 | 14.8% | 9.1% |
| Failure to capture | 188 | 11.6% | 12.6% |
| High capture threshold | 167 | 10.3% | 10.7% |
| Breakthe device broke | 144 | 8.9% | 5.2% |
| Low impedance | 139 | 8.6% | 5.1% |
| Capturing problem | 112 | 6.9% | 4.7% |
| Fracturea broken bone | 109 | 6.7% | 4.7% |
| Pacing problem | 47 | 2.9% | 4.4% |
| Device sensing problem | 35 | 2.2% | 3.7% |
| Device dislodged or dislocated | 34 | 2.1% | 15.8% |
| Intermittent capture | 34 | 2.1% | 1.1% |
| Insufficient device problem information | 33 | 2% | 2.6% |
| Impedance problem | 30 | 1.9% | 2.2% |
| Failure to sense | 26 | 1.6% | 2% |
| Under-sensing | 25 | 1.5% | 4.5% |
| Difficult to position | 16 | 1% | 0.3% |
| Failure to disconnect | 16 | 1% | 0.2% |
| Difficult to insertthe device was hard to insert | 15 | 0.9% | 0.5% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 60 | 3.7% |
| Dizzinesslight-headedness or unsteadiness | 37 | 2.3% |
| Syncopefainting | 36 | 2.2% |
| Discomfortdiscomfort | 19 | 1.2% |
| Arrhythmia | 17 | 1% |
| Bradycardiaslow heart rate | 15 | 0.9% |
| Muscle stimulation | 12 | 0.7% |
| Pocket erosion | 11 | 0.7% |
| Syncope/fainting | 11 | 0.7% |
| Dyspneashortness of breath | 8 | 0.5% |
| Fatiguetiredness | 6 | 0.4% |
| Chest painchest pain | 5 | 0.3% |
| Fever | 5 | 0.3% |
| Complaint, ill-defined | 4 | 0.2% |
| Cardiac arrestthe heart stopped | 3 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Isoflex S Lead | Product code NVN | All MAUDE reports |
|---|---|---|---|
| Reports | 1,620 | 229,796 | 26,136,888 |
| Share of that pool | — | 0.7% | 0% |
| Classified as death, per 1,000 reports | 44 | 22 | 9 |
| Classified as injury | 48.4% | 56.2% | 36.2% |
| Classified as malfunction | 47.2% | 41.6% | 62.3% |
| Filed by the manufacturer | 99.9% | 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 Isoflex S Lead reports
How many FDA reports name Isoflex S Lead?
1,620 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 64 in the latest 12 months.
What kinds of events are reported?
injury (48.4%), malfunction (47.2%) and death (4.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
over-sensing (27.3%), signal artifact/noise (15%), high impedance (14.8%), failure to capture (11.6%) and high capture threshold (10.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Isoflex S 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.