Devices › Permanent defibrillator electrodes
Device brand name · Implantable lead
Endotak Endurance: medical device reports filed with FDA
1,045 reports name it, 1999–2025. Manufacturer given most often on reports: Cpi - Del Caribe. Product code NVY.
- 1,045
- device reports naming the brand
- 0% of all MAUDE reports · about 38 a year
- 1
- reports, 12 months to August 2026
- 2 in the 12 months before
- 27.4%
- classified as malfunction
- 41.2% across the product code
- 1.6%
- classified as death, as reported
- 17 reports · not verified by FDA
FDA's MAUDE database holds 1,045 reports that name the brand "Endotak Endurance" (implantable lead), received between February 1999 and October 2025; the manufacturer given most often on reports is Cpi - Del Caribe. Spellings of one product vary from report to report.
1 reports arrived in the 12 months to August 2026, down 50% from 2 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 (71%), malfunction (27.4%) and death (1.6%); 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 high impedance (31.5%), over-sensing (13.2%) and device sensing problem (12%). The patient problems coded most often are pocket erosion, cardiac arrest and complaint, ill-defined. 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 |
|---|---|---|---|
| High impedance | 329 | 31.5% | 20% |
| Over-sensing | 138 | 13.2% | 22.8% |
| Device sensing problem | 125 | 12% | 5% |
| Fracturea broken bone | 101 | 9.7% | 5.4% |
| Failure to capture | 93 | 8.9% | 8.1% |
| Material integrity problema problem with the device material | 76 | 7.3% | 1.1% |
| Pacing problem | 75 | 7.2% | 2.1% |
| Low impedance | 74 | 7.1% | 6% |
| Ambient noise problem | 61 | 5.8% | 3.7% |
| Insufficient device problem information | 61 | 5.8% | 2.1% |
| Inappropriate/inadequate shock/stimulation | 50 | 4.8% | 8.5% |
| Capturing problem | 29 | 2.8% | 3.7% |
| Connection problema connection problem | 20 | 1.9% | 0.5% |
| Device displays incorrect message | 20 | 1.9% | 0.1% |
| Impedance problem | 16 | 1.5% | 3.1% |
| Defibrillation/stimulation problem | 14 | 1.3% | 0.4% |
| Device operates differently than expectedthe device behaved unexpectedly | 14 | 1.3% | 0.6% |
| Loss of threshold | 11 | 1.1% | 0% |
| Under-sensing | 11 | 1.1% | 2.5% |
| Difficult to removethe device was hard to remove | 10 | 1% | 0.2% |
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 |
|---|---|---|
| Pocket erosion | 46 | 4.4% |
| Cardiac arrestthe heart stopped | 16 | 1.5% |
| Complaint, ill-defined | 14 | 1.3% |
| Deaththe patient died; cause not stated by this term | 13 | 1.2% |
| Syncopefainting | 11 | 1.1% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 9 | 0.9% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 9 | 0.9% |
| Endocarditis | 7 | 0.7% |
| Surgical procedure, repeated | 7 | 0.7% |
| Atrial fibrillationan irregular heart rhythm | 6 | 0.6% |
| Erosion | 6 | 0.6% |
| Falla fall | 6 | 0.6% |
| Sepsisa severe body-wide response to infection | 6 | 0.6% |
| Foreign body in patientpart of a device left in the patient | 5 | 0.5% |
| Other (for use when an appropriate patient code cannot be identified) | 5 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endotak Endurance | Product code NVY | All MAUDE reports |
|---|---|---|---|
| Reports | 1,045 | 138,578 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 16 | 22 | 9 |
| Classified as injury | 71% | 56.5% | 36.2% |
| Classified as malfunction | 27.4% | 41.2% | 62.3% |
| Filed by the manufacturer | 99.9% | 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% |
| Isoflex Optim Lead | 7,889 | 437 | 2% |
| 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% |
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 Endotak Endurance reports
How many FDA reports name Endotak Endurance?
1,045 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1 in the latest 12 months.
What kinds of events are reported?
injury (71%), malfunction (27.4%) and death (1.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
high impedance (31.5%), over-sensing (13.2%), device sensing problem (12%), fracture (9.7%) and failure to capture (8.9%). 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 Endotak Endurance 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.