# P920015: Medtronic (R) Transvene Lead System

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Dec 9, 1993 after 617 days
- Product code: NVY (Permanent Defibrillator Electrodes)
- Device class: 3
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Nov 8, 2021 · Class II · Z-0390-2022: 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: 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: 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 additi
- Oct 15, 2007 · Not classified · Z-0069-2008: 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 additi
- Oct 15, 2007 · Not classified · Z-0070-2008: 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 additi
- Oct 15, 2007 · Not classified · Z-0068-2008: 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 additi

Source page: https://510kreport.com/device/P920015
Methodology: https://510kreport.com/methodology