A former subject in the (b)(6) was converted to a maestro rechargeable system on (b)(6) 2015.At the conversion procedure, the original investigational rf neuroregulator was replaced with the commercial model 2002 rechargeable neuroregulator.The anterior and posterior leads, implanted as part of the (b)(6) clinical trial on (b)(6) 2008, were not replaced at the time of conversion to the rechargeable system.On (b)(6) 2015 the site reported that this patient was experiencing low impedance of the anterior lead with related error codes.Therapy was restarted but then this issue returned.Review of radiograph images suggest that this issue was caused by excessive device manipulation by the patient.The system, including model 2002 rechargeable neuroregulator, model 2200a-47e anterior lead, and model 2200p-47e posterior lead were replaced on (b)(6) 2016.Mdrs related to this issue are: mdr3005025697-2017-00005: model 2002 rechargeable neuroregulator; mdr3005025697-2017-00006: model 2200a-47e anterior lead; mdr3005025697-2017-00007: model 2200p-47e posterior lead.
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