Concomitant medical products: product id: 3389s-40, lot# va0jfyt, implanted: (b)(6) 2014, product type: lead.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4) implanted: (b)(6) 2014, product type: extension.Product id: 37603, serial# (b)(4) implanted: (b)(6) 2013, product type: implantable neurostimulator.Product id: 3389s-40, lot# va0awnj, implanted: (b)(6) 2013, product type: lead.Product id: 3708660, lot# serial# (b)(4) implanted: (b)(6) 2013-09-30, product type: extension.(b)(4).
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It was reported that there was skin erosion over the stim loc burrhole cover.The action required as a result of the event was surgical intervention, the skin was repaired and the deep brain stimulator system was left in place.No diagnostic testing or troubleshooting was performed as it was not required.It was unknown if any symptoms or complications were associated with the event.The cause of the incident was unknown and it was also unknown if it was device related.As far as the manufacturing representative was aware, therapy had not been disrupted and was working properly.The patient¿s condition was otherwise unknown.No outcome was provided.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.
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