PMA · Approved
Recalled · Class II · 2026Synergyst II Pulse Generator Models 7070 & 7071
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · NVZ Pulse Generator, Permanent, Implantable
Approved on Aug 24, 1989 through premarket approval, which rests on the device’s own clinical evidence after a 231-day review. 1 later device descends from it. It has been recalled 13 times.
- Decided
- Aug 24, 1989
- Review
- 231 days
- Class
- Class III
- Product code
- NVZ
- Recalls
- 13
1 later device descends from it, 1 citing it directly.
- This deviceP890003 Synergyst II Pulse Generator Models 7070 & 7071Medtronic, Inc. · 1989
- Descendant · cites it directly · 0 of its ownK163008 CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K163008CareLink SmartSync Device Manager - Pacing System AnalyzerMedtronic, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P890003 | Synergyst II Pulse Generator Models 7070 & 7071 | Medtronic, Inc. | 1989 | — |
| +1 | K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | Medtronic, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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 NVZ? 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163008 | CareLink SmartSync Device Manager - Pacing System Analyzer | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 24, 2026 | Not classified | Z-0302-2027 | Software design | Software problem has the potential for an inaccurate displayed longevity estimate. |
| Sep 24, 2026 | Not classified | Z-0303-2027 | Software design | Software problem has the potential for an inaccurate displayed longevity estimate. |
| Sep 24, 2026 | Not classified | Z-0304-2027 | Software design | Software problem has the potential for an inaccurate displayed longevity estimate. |
| Jun 18, 2025 | Class II | Z-2169-2025 | Software design | 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 limiting the user's ability to cancel a… |
| Jun 18, 2025 | Class II | Z-2168-2025 | Software design | 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 limiting the user's ability to cancel a… |
| Jun 17, 2025 | Class II | Z-2128-2025 | Software design | 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 interrogation with a SmartSync Device… |
| Jun 17, 2025 | Class II | Z-2127-2025 | Software design | 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 interrogation with a SmartSync Device… |
| Jun 4, 2020 | Class II | Z-2505-2020 | Software design | 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 measurements, Capture Management", Atrial Lead… |
| Jun 4, 2020 | Class II | Z-2506-2020 | Software design | 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 measurements, Capture Management", Atrial Lead… |
| Jan 17, 2019 | Class II | Z-0845-2019 | Device Design | 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 mode of the power supply has been… |
| Jul 14, 2017 | Class II | Z-0399-2018 | Error in labeling | 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. Potential impacts could lead to missed… |
| Jul 14, 2017 | Class II | Z-0400-2018 | Error in labeling | 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. Potential impacts could lead to missed… |
| Jun 11, 2010 | Not classified | Z-2209-2010 | Software change control | 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 to transmit device data via CareLink.… |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K163008 (Medtronic, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NVZ devicesNVZ Pulse Generator, Permanent, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NVZ
39in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NVZ
Too few NVZ 510(k)s in any year since 2007 to give a median.
Recalls per year · NVZ
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · NVZ
5,970in 2025
MAUDE reports naming product code NVZ, 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 | 124 | — | 2 | 85 |
| 2008 | 164 | — | 1 | 142 |
| 2009 | 124 | — | 4 | 245 |
| 2010 | 181 | — | 1 | 4,039 |
| 2011 | 178 | — | 1 | 6,334 |
| 2012 | 130 | — | 0 | 5,562 |
| 2013 | 131 | — | 0 | 4,033 |
| 2014 | 122 | — | 1 | 3,107 |
| 2015 | 88 | — | 0 | 2,773 |
| 2016 | 76 | — | 0 | 2,558 |
| 2017 | 61 | — | 2 | 3,164 |
| 2018 | 59 | — | 0 | 5,878 |
| 2019 | 60 | — | 7 (7) | 8,188 |
| 2020 | 73 | — | 0 | 8,337 |
| 2021 | 40 | — | 1 | 8,538 |
| 2022 | 44 | — | 0 | 7,791 |
| 2023 | 39 | — | 0 | 8,463 |
| 2024 | 42 | — | 2 | 6,496 |
| 2025 | 39 | — | 0 | 5,970 |
| 2026 | 24 | — | 3 | — |
https://510kreport.com/device/P890003 · printed Nov 6, 2026
Cite this page
510(k) Report. “P890003: Synergyst II Pulse Generator Models 7070 & 7071.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P890003
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026