We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
Recall devices: Defects at initial visit and during remote monitoring supported follow‐up.
- Authors
Grymuza, Maciej; Chmielewska‐Michalak, Lidia; Katarzyńska‐Szymańska, Agnieszka; Migaj, Jacek; Lesiak, Maciej; Mitkowski, Przemysław
- Abstract
Background: In March 2021, Biotronik informed about the risk of premature battery depletion in a group of implantable cardioverter‐defibrillators. Following the manufacturers' recommendation, our center executed a recall and introduced remote monitoring (RM) in patients with susceptible devices. This study reports the rate of premature battery depletion in our center and events found in RM‐supported follow‐up. Methods: Single‐center observational study. Results: Out of the 206 susceptible implanted devices, 125 patients appeared for the visit and RM was introduced in 107 (83%) patients. Until the visit, three (2.4%) devices required replacement due to battery depletion, and a further three (2.4%) devices had unexpected battery depletion during follow‐up. Conclusions: The recalled devices had a higher rate of battery exhaustion than expected, while other device or lead defects were less common.
- Subjects
REMOTE access networks; MEDICAL equipment reliability; SCIENTIFIC observation; IMPLANTABLE cardioverter-defibrillators; ELECTRIC power supplies to apparatus
- Publication
Pacing & Clinical Electrophysiology, 2022, Vol 45, Issue 11, p1320
- ISSN
0147-8389
- Publication type
Article
- DOI
10.1111/pace.14552