Key Details of SPDRL1 (Sphera DR MRI SureScan):
- Model Number: SPDRL1.
- Dimensions: Approximately \(45.4\text{ mm} \times 52.3\text{ mm} \times 7.5\text{ mm}\).
- Features: Dual-chamber (DDDR) pacing, MRI-compatible (SureScan), Rate Responsive.
- Indications: Used for patients requiring atrial, ventricular, or dual-chamber pacing.
- Contraindications: Not for use in patients with chronic atrial fibrillation, as it is a dual-chamber device, which may be inappropriate for these patients, or in those where the device circuit error might be risky (e.g., lack of inherent ventricular escape rhythm).
Notes on Safety and Performance:
- A previous Field Safety Notice (FSN) in 2019 identified a potential circuit error risk, prompting, in some cases, a software update.
- Longitudinal data (as of 2024) indicates good system durability.
