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

Platinium SonR CRT-D

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.

 

644DL019
650DL05E

1811

Manufacturer

Microport CRM S.R.L.
VIA CRESCENTINO S.N.,
SALUGGIA, VERCELLI
13040
ITALY

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