The patient received two new waas, and the shocking sensation ceased.Per (b)(4) and (b)(4) the investigation found no issue with the units and were unable to replicate the alleged issue.The setting on the devices follows the parameter for surge mode consisting on rate 500 hz and width of 800 us.After the incident the patient was provide with replacement programmed with the same parameters, and the issue did not arise again.The device was tested and verified to meet specification, and no root cause was identified for the reported incident.Based on this information, the shock/jolt was not confirmed/replicated.The mild shock felt by the patient could be electrical sensation/parasthesia.Based on the stimulator investigation, there is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the shock/jolt is unknown; no problem found.Design fmea (b)(4) and hra (b)(4) was reviewed and painful and overstimulation due are known issues with mitigation controls in place to reduce risk as far as possible.
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