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
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
Platinium SonR CRT-D
Lot or serial number
644DL019
650DL05E
Model or catalog number
1811
Companies
- Manufacturer
-
Microport CRM S.R.L.
VIA CRESCENTINO S.N.,
SALUGGIA, VERCELLI
13040
ITALY