Recall devices: Defects at initial visit and during remote monitoring supported follow‐up

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.

Implementation of remote monitoring in patients implanted with T-ICD and S-ICD involved in a recall campaign: An excellent tool with insufficient availability

“…Taking into account 3 patients diagnosed with battery depletion on the RM enrollment visit and further 5 cases identified during follow-up, this complication was finally diagnosed in 3.5% of patients. This is a lower percentage than suggested by other authors (4.8%), which may be due to a shorter follow-up time (6 vs. 8 months) [4]. Data from the extended ELISIR experience (Experience from the Long-term Italian S-ICD registry) reported premature unanticipated device battery depletion in 2.2% of patients and lead fracture in 0.3%, which is in line with the expected rates reported by Boston Scientific [5].…”

Acute myocardial infarction revealed by recurrent ventricular tachyarrhythmias detected by remote monitoring

“…Remote monitoring (RM) of patients with cardiac implantable electronic devices (CIED) played an important role in advancement of clinical practice with a particular added value in case of CIED components that have been recalled or were on advisory 1. RM has been demonstrated to allow safe reduction of in-office visits with saving of resources for both patients and health service 2.…”