The pt.(consumer) indicated he has atrial fibrillation from a preexisting condition.The warnings! section of the instructions for use states: do not use this device if you are susceptible to rhythm disturbances to the heart unless under the direction of your physician.The pt.Stated he purchased the device on the internet without obtaining his physician's advice.He agreed not to continue using the device until he obtains advice from his physician.The pt.Stated he has used other manufacturers tens devices which he obtained through his physician at the (b)(6).The report was not a problem with the device, therefore, the device was not returned for evaluation.The dhr was reviewed which showed the device performed to specification when it was manufactured.There are no similar reports of atrial fibrilation from use of the device.The conclusion is this is an isolated event related to a pt.Preexisting condition and the pt.Did not read the warnings! section of the instructions for use: do not use this device if you are susceptible to rhythm disturbances to the heart unless under the direction of your physician.
|