# P890003: Synergyst  II Pulse Generator Models 7070 & 7071

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Aug 24, 1989 after 231 days
- Product code: NVZ (Pulse Generator, Permanent, Implantable)
- Device class: 3
- Recalls of this device: 13 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K163008: CareLink SmartSync Device Manager - Pacing System Analyzer (2017), 0 descendants of its own

## Recalls of this device
- Sep 24, 2026 · Not classified · Z-0302-2027: Software problem has the potential for an inaccurate displayed longevity estimate.
- Sep 24, 2026 · Not classified · Z-0303-2027: Software problem has the potential for an inaccurate displayed longevity estimate.
- Sep 24, 2026 · Not classified · Z-0304-2027: Software problem has the potential for an inaccurate displayed longevity estimate.
- Jun 18, 2025 · Class II · Z-2169-2025: In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limi
- Jun 18, 2025 · Class II · Z-2168-2025: In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limi
- Jun 17, 2025 · Class II · Z-2128-2025: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon inter
- Jun 17, 2025 · Class II · Z-2127-2025: A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon inter
- Jun 4, 2020 · Class II · Z-2505-2020: There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurem
- Jun 4, 2020 · Class II · Z-2506-2020: There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurem
- Jan 17, 2019 · Class II · Z-0845-2019: There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic Model 29901 CareLink Encore programmer. A failure 
- Jul 14, 2017 · Class II · Z-0399-2018: Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Pote
- Jul 14, 2017 · Class II · Z-0400-2018: Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Pote
- Jun 11, 2010 · Not classified · Z-2209-2010: Medtronic has identified that a subset of 2490C CareLink Monitors recently received an incorrect software update. Patients reported that their monitor was making a "ticking sound" and they were unable

Source page: https://510kreport.com/device/P890003
Methodology: https://510kreport.com/methodology