Product Wiki · Recalls · Health Canada — Medical Devices

EV ICD Pivotal Clinical Device (2020-08-13) — recall 61600

Health Canada — Medical Devices · Canada · 2020-09-15 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
61600
Date of alert
2020-09-15
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Potential for an unintended device setting to occur with EV ICD investigational system after a pacing threshold test due to a device software code interaction. Specifically, the last ventricular sensitivity value used during an EV ICD pacing threshold test will be retained in device memory and used during arrhythmia confirmation instead of the device's permanent sensitivity setting. If the retained sensitivity setting is a higher value than the desired, permanent setting, there is a risk of undersensing during arrhythmia confirmation which could delay or abort an anti-tachy pacing or high voltage therapy. It is only during arrhythmia confirmation that this retained sensitivity setting is applied.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ev-icd-pivotal-clinical-device

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