Device 1 of 2.Reference mfr report: 1627487-2015-10089.The patient had two leads implanted with the same lot number.A review of the patient's medical chart identified the following information: on (b)(6) 2009, low impedances were observed during reprogramming.On (b)(6) 2009, x-ray's confirmed migration of the right lead.On (b)(6) 2009, the patient's entire scs system was removed.It was noted the loss of stimulation pattern was possibly confounded by fluid development at the ipg site consistent with seroma.
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The 1627487-05242011-002-r, 1627487-07262012-002-r, 1627487-12192011-003-r, this ipg serial number was included in three field advisories.(b)(4).Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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