# P010031: Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization

- Pathway: PMA
- Applicant: Medtronic Cardiac Rhythm Disease Management
- Decided: Jun 26, 2002 after 418 days
- Product code: NIK (Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D))
- Device class: 3
- Recalls of this device: 11 (1 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.
1 of 1 device in its family (counting itself) has 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
- 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
- Apr 6, 2021 · Class II · Z-1528-2021: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other devi
- Apr 6, 2021 · Class II · Z-1526-2021: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other devi
- Apr 6, 2021 · Class II · Z-1527-2021: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other devi
- Apr 6, 2021 · Class II · Z-1525-2021: A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other devi
- Feb 3, 2021 · Class I · Z-1306-2021: A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-ex
- Nov 15, 2020 · Class II · Z-0928-2021: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
- Nov 15, 2020 · Class II · Z-0926-2021: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
- Nov 15, 2020 · Class II · Z-0927-2021: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
- Jul 25, 2008 · Not classified · Z-0667-2009: Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors dail

Source page: https://510kreport.com/device/P010031
Methodology: https://510kreport.com/methodology