It was reported that approximately two weeks after implant surgery ((b)(6) 2014), the neurologist turned on the patient¿s device to 0.25ma.During this time, the incision site became reddened.The patient¿s caregiver applied 40% zinc oxide which decreased the redness.When he saw the surgeon for follow up, the surgeon indicated that the incision had healed well.With continued increase in settings at following dosing appointment(s), it was reported that the area of the generator has become red and inflamed again in spite of the 40% zinc oxide.The neurologist advised that the patient see the surgeon.The caregiver felt like the patient¿s body may have been rejecting the device.She thought that she could see the metal of the generator through the skin.It was felt that the patient may have been picking at his device and that the mother reportedly removed the dressing earlier than advised.Hygiene may have also have been a contributing factor.The surgeon reported that the patient¿s skin over the generator has ¿basically sloughed off.¿ the patient was scheduled for explant surgery due to infection.Device diagnostics were reportedly within normal limits.Explant of the generator and portion of the lead occurred on (b)(6) 2015.At that time, the surgeon stated he felt that the issue was an allergic reaction more so than an infection.The patient saw plastic surgery on (b)(6) 2015 for the wound, they feel that they can suture rather than skin graft the chest.
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