The risks associated with the microtransponder include the following:
- Adverse tissue reaction
- Migration of the transponder
- Failure of the microtransponder to operate properly
- Failure of the inserter
- Failure of the electrical scanner
- Electromagnetic interference
- Electrical hazards
- MRI disturbances
These risks have been mitigated through the establishment of certain testing requirements by the FDA for this device, including the requirement to perform biocompatibility testing, migration testing, performance testing, electromagnetic compatibility testing, electrical safety testing, and MRI compatibility testing.