Platinium SonR CRT-D (2018-12-22)

Starting date:

December 22, 2018

Posting date:

January 9, 2019

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-68670

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  Reason
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  Affected products

Affected products

Platinium SonR CRT-D

Reason

On a subset of Platinium ICD and CRT-D devices, a specific hardware configuration was identified as potentially defective over time, leading to overconsumption, immediately followed by loss of pacing and sensing capabilities in all cavities. As a result of the loss of sensing capability, the device cannot identify an arrhythmia that would require a defibrillation shock therapy.

Affected products