EV ICD Pivotal Clinical Device (2020-08-13)

Starting date:

August 13, 2020

Posting date:

September 15, 2020

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-73913

Last updated: 2020-09-15

• Reason
• Affected products

Affected Products

EV ICD Pivotal Clinical Device

Reason

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.

Affected products