Devices › Permanent defibrillator electrodes
Device brand name · Defibrillation lead
Spl Lead Transvenous: medical device reports filed with FDA
448 reports name it, 2008–2026. Manufacturer given most often on reports: St Jude Medical Cardiac Rhythm Management Division. Product code NVY.
- 448
- device reports naming the brand
- 0% of all MAUDE reports · about 25 a year
- 13
- reports, 12 months to August 2026
- 12 in the 12 months before
- 44.9%
- classified as malfunction
- 41.2% across the product code
- 2%
- classified as death, as reported
- 9 reports · not verified by FDA
448 medical device reports received by FDA name the brand "Spl Lead Transvenous" (defibrillation lead); the manufacturer given most often on reports is St Jude Medical Cardiac Rhythm Management Division; received from September 2008 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
13 reports arrived in the 12 months to August 2026, close to the 12 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 (53.1%), malfunction (44.9%) 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 (27.7%), break (17.4%) and high impedance (14.7%). The patient problems coded most often are failure of implant, shock from patient lead(s) and surgical procedure. 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 | 124 | 27.7% | 22.8% |
| Breakthe device broke | 78 | 17.4% | 8.8% |
| High impedance | 66 | 14.7% | 20% |
| Inappropriate/inadequate shock/stimulation | 50 | 11.2% | 8.5% |
| Low impedance | 44 | 9.8% | 6% |
| Fracturea broken bone | 33 | 7.4% | 5.4% |
| Signal artifact/noise | 23 | 5.1% | 6.6% |
| High capture threshold | 12 | 2.7% | 8.1% |
| Impedance problem | 11 | 2.5% | 3.1% |
| Invalid sensing | 10 | 2.2% | 0.1% |
| Failure to capture | 9 | 2% | 8.1% |
| Decreased sensitivity | 7 | 1.6% | 2% |
| Device operates differently than expectedthe device behaved unexpectedly | 7 | 1.6% | 0.6% |
| Device sensing problem | 7 | 1.6% | 5% |
| Low sensing threshold | 7 | 1.6% | 1.1% |
| Noise | 6 | 1.3% | 0.1% |
| Defibrillation/stimulation problem | 5 | 1.1% | 0.4% |
| High sensing threshold | 4 | 0.9% | 0.3% |
| Intermittent capture | 4 | 0.9% | 0.6% |
| Aborted charge | 3 | 0.7% | 0.1% |
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 |
|---|---|---|
| Failure of implant | 20 | 4.5% |
| Shock from patient lead(s) | 18 | 4% |
| Surgical procedure | 11 | 2.5% |
| Deaththe patient died; cause not stated by this term | 8 | 1.8% |
| Therapeutic effects, unexpected | 8 | 1.8% |
| Device overstimulation of tissue | 3 | 0.7% |
| Foreign body in patientpart of a device left in the patient | 2 | 0.4% |
| Pocket erosion | 2 | 0.4% |
| Syncopefainting | 2 | 0.4% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 2 | 0.4% |
| Ventricular tachycardiaa fast rhythm from the lower heart chambers | 2 | 0.4% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 1 | 0.2% |
| Cardiac perforation | 1 | 0.2% |
| Complaint, ill-defined | 1 | 0.2% |
| Device embedded in tissue or plaque | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Spl Lead Transvenous | Product code NVY | All MAUDE reports |
|---|---|---|---|
| Reports | 448 | 138,578 | 26,136,888 |
| Share of that pool | — | 0.3% | 0% |
| Classified as death, per 1,000 reports | 20 | 22 | 9 |
| Classified as injury | 53.1% | 56.5% | 36.2% |
| Classified as malfunction | 44.9% | 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% |
| 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 Spl Lead Transvenous reports
How many FDA reports name Spl Lead Transvenous?
448 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.
What kinds of events are reported?
injury (53.1%), malfunction (44.9%) 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 (27.7%), break (17.4%), high impedance (14.7%), inappropriate/inadequate shock/stimulation (11.2%) and low impedance (9.8%). 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 Spl Lead Transvenous 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.