Devices › Permanent pacemaker electrode
Device brand name · Permanent pacemaker electrode
Isoflex Lead: medical device reports filed with FDA
436 reports name it, 2008–2015. Manufacturer given most often on reports: St Jude Medical Cardiac Rhythm Management Division. Product code DTB.
- 436
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 37.6%
- classified as malfunction
- 43.9% across the product code
- 0.9%
- classified as death, as reported
- 4 reports · not verified by FDA
436 medical device reports received by FDA name the brand "Isoflex Lead" (permanent pacemaker electrode); the manufacturer given most often on reports is St Jude Medical Cardiac Rhythm Management Division; received from November 2008 to May 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (61.2%), malfunction (37.6%) and death (0.9%); across all permanent pacemaker electrode reports (product code DTB) death is recorded in 2.9% and malfunction in 43.9%. 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 (51.8%), failure to capture (16.1%) and over-sensing (13.5%). The patient problems coded most often are muscle stimulation, surgical procedure 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
No report naming Isoflex Lead was received in the five years to August 2026; the latest was received in May 2015.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 327,317 reports carrying product code DTB. 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 | 226 | 51.8% | 9.1% |
| Failure to capture | 70 | 16.1% | 9.7% |
| Over-sensing | 59 | 13.5% | 13.2% |
| Failure to sense | 52 | 11.9% | 1% |
| High sensing threshold | 46 | 10.6% | 2.3% |
| Device sensing problem | 29 | 6.7% | 1.9% |
| Under-sensing | 18 | 4.1% | 17.1% |
| High capture threshold | 16 | 3.7% | 12.3% |
| Dislodged | 13 | 3% | 1.8% |
| Decreased sensitivity | 12 | 2.8% | 2.4% |
| Low sensing threshold | 12 | 2.8% | 0.1% |
| Implant, repositioning of | 11 | 2.5% | 0.2% |
| Capturing problem | 10 | 2.3% | 4.2% |
| High impedance | 10 | 2.3% | 10.7% |
| Breakthe device broke | 8 | 1.8% | 1.8% |
| Low impedance | 8 | 1.8% | 5.3% |
| Difficult to advance | 6 | 1.4% | 0% |
| Intermittent capture | 4 | 0.9% | 1.4% |
| Difficult to insertthe device was hard to insert | 2 | 0.5% | 0.1% |
| Explanted | 2 | 0.5% | 1.2% |
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 |
|---|---|---|
| Muscle stimulation | 20 | 4.6% |
| Surgical procedure | 12 | 2.8% |
| Deaththe patient died; cause not stated by this term | 6 | 1.4% |
| Undesired nerve stimulation | 6 | 1.4% |
| Twiddlers syndrome | 3 | 0.7% |
| Device embedded in tissue or plaque | 2 | 0.5% |
| Dizzinesslight-headedness or unsteadiness | 2 | 0.5% |
| Palpitationsawareness of the heartbeat | 2 | 0.5% |
| Shockshock, a collapse of the circulation | 2 | 0.5% |
| Atrial fibrillationan irregular heart rhythm | 1 | 0.2% |
| Cardiac tamponade | 1 | 0.2% |
| Discomfortdiscomfort | 1 | 0.2% |
| Dyspneashortness of breath | 1 | 0.2% |
| Failure of implant | 1 | 0.2% |
| Fainting | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Isoflex Lead | Product code DTB | All MAUDE reports |
|---|---|---|---|
| Reports | 436 | 327,317 | 26,136,888 |
| Share of that pool | — | 0.1% | 0% |
| Classified as death, per 1,000 reports | 9 | 29 | 9 |
| Classified as injury | 61.2% | 53.1% | 36.2% |
| Classified as malfunction | 37.6% | 43.9% | 62.3% |
| Filed by the manufacturer | 100% | 96.8% | 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 DTB
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| CapSureFix Novus Lead MRI SureScan | 108,103 | 17,554 | 1% |
| Capsurefix Novus | 57,538 | 4 | 6.8% |
| CapSureFix Novus MRI SureScan | 18,909 | 3,243 | 1.3% |
| CapSure Sense Lead MRI SureScan | 8,774 | 1,337 | 1% |
| CapSure SP | 8,223 | 226 | 3.9% |
| Capsurefix | 7,284 | 0 | 6.3% |
| Permanent Pacemaker Electrode | 5,041 | 332 | 0.4% |
| Capsure Sp Novus | 4,803 | 0 | 9.5% |
| Capsure Sense | 4,740 | 0 | 6.4% |
| Flextend | 6,836 | 203 | 0.7% |
| Attain Otw | 7,773 | 0 | 9.1% |
| Tendril Sdx | 8,316 | 3 | 2.3% |
| CapSure Epicardial Lead | 4,842 | 760 | 1.5% |
| Tendril Sts | 54,036 | 4,320 | 3.1% |
| CapSure SP Novus Lead | 2,715 | 331 | 1.1% |
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 Lead reports
How many FDA reports name Isoflex Lead?
436 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (61.2%), malfunction (37.6%) and death (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (51.8%), failure to capture (16.1%), over-sensing (13.5%), failure to sense (11.9%) and high sensing threshold (10.6%). 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 Isoflex 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.