CARELINK SMARTSYNC DEVICE MANAGER (2020-12-18)

Starting date:

December 18, 2020

Posting date:

January 7, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74709

Last updated:
2021-01-07

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  Reason
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  Affected products

Affected Products 

CARELINK SMARTSYNC DEVICE MANAGER

Reason

This update addresses a rare communication sequence during the first device interrogation with a Smartsync device manager that may result in the temporary suspension of some device features (i.e., battery measurements, capture management, atrial lead position check, effectivcrt algorithms, and adaptivcrt).This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

Affected products