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EON MINI NEUROSTIMULATION SYSTEM-CHARGING SYSTEM AND IPG (2015-10-15)
- Starting date:
- October 15, 2015
- 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-55770
Affected Products
EON MINI NEUROSTIMULATION SYSTEM-CHARGING SYSTEM AND IPG
Reason
Some patients have reported experiencing an uncomfortable temperature increase at the implantable pulse generators (IPG) implant site during charging, with a small number of patients reporting burns at the implant site.
Affected products
EON MINI NEUROSTIMULATION SYSTEM-CHARGING SYSTEM AND IPG
Lot or serial number
All lots
Model or catalog number
- 3721
- 3788
Companies
- Manufacturer
-
St. Jude Medical
6901 Preston Road
Plano
75024
Texas
UNITED STATES