Health product recall

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

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

EV ICD Pivotal Clinical Device

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

DVEX3E4

Companies
Manufacturer

Medtronic Inc.

710 Medtronic Parkway

Minneapolis

55432

Minnesota

UNITED STATES