PMA · Approved
Recalled · Class II · 2021Medtronic (R) Transvene Lead System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NVY Permanent Defibrillator Electrodes
Approved on Dec 9, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 617-day review. It has been recalled 6 times.
- Decided
- Dec 9, 1993
- Review
- 617 days
- Class
- Class III
- Product code
- NVY
- Recalls
- 6
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P920015 has 294 supplements since 1994: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 1994 | 3 |
| 1995 | 3 |
| 1996 | 5 |
| 1997 | 2 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 6 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 3 |
| 2007 | 1 |
| 2008 | 11 |
| 2009 | 5 |
| 2010 | 13 |
| 2011 | 13 |
| 2012 | 17 |
| 2013 | 23 |
| 2014 | 19 |
| 2015 | 17 |
| 2016 | 26 |
| 2017 | 14 |
| 2018 | 20 |
| 2019 | 15 |
| 2020 | 13 |
| 2021 | 12 |
| 2022 | 10 |
| 2023 | 11 |
| 2024 | 12 |
| 2025 | 5 |
| 2026 | 6 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NVY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 8, 2021 | Class II | Z-0390-2022 | Error in labeling | The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted." |
| Nov 8, 2021 | Class II | Z-0391-2022 | Error in labeling | The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted." |
| Oct 15, 2007 | Not classified | Z-0067-2008 | Device Design | Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new… |
| Oct 15, 2007 | Not classified | Z-0069-2008 | Device Design | Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new… |
| Oct 15, 2007 | Not classified | Z-0070-2008 | Device Design | Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new… |
| Oct 15, 2007 | Not classified | Z-0068-2008 | Device Design | Medtronic Cardiac Rhythm Disease Management has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All NVY devicesNVY Permanent Defibrillator Electrodes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NVY
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVY
Too few NVY 510(k)s in any year since 2007 to give a median.
Recalls per year · NVY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NVY
11,513in 2025
MAUDE reports naming product code NVY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | — | 0 | 48 |
| 2008 | 27 | — | 0 | 63 |
| 2009 | 30 | — | 0 | 103 |
| 2010 | 82 | — | 0 | 1,796 |
| 2011 | 89 | — | 0 | 6,003 |
| 2012 | 92 | — | 0 | 8,520 |
| 2013 | 96 | — | 0 | 7,224 |
| 2014 | 86 | — | 0 | 9,530 |
| 2015 | 52 | — | 0 | 8,840 |
| 2016 | 39 | — | 0 | 8,567 |
| 2017 | 14 | — | 0 | 8,452 |
| 2018 | 20 | — | 0 | 8,322 |
| 2019 | 15 | — | 0 | 8,324 |
| 2020 | 13 | — | 0 | 8,020 |
| 2021 | 12 | — | 1 | 8,059 |
| 2022 | 10 | — | 2 | 7,636 |
| 2023 | 12 | — | 0 | 10,442 |
| 2024 | 12 | — | 0 | 9,362 |
| 2025 | 9 | — | 0 | 11,513 |
| 2026 | 10 | — | 1 | — |
https://510kreport.com/device/P920015 · printed Nov 3, 2026
Cite this page
510(k) Report. “P920015: Medtronic (R) Transvene Lead System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/P920015
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026