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Potential packaging breaches of inner blister and outer sterile blister.
Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.