Additional information was received from a legal representative of the patient reporting that for the first year and a half the device functioned properly.However, around (b)(6) 2017, the patient began experiencing problems with his device.The device would get so hot at the battery site that it would burn the patient¿s skin and caused blistering.Due to the severe heat generated by the device¿s battery, the patient was no longer able to use their device.The patient was told that the battery and leads must both be removed, otherwise an mri, if ever needed, would ¿cook¿ their spine.When the patient discussed removing the device and leads, the doctor said, ¿i¿ll take out the leads but if you get paralyzed, it¿s on you.¿ the unit was dormant and remains in the patient¿s body.
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