It was reported that it appeared that a lead wire had worked itself to the surface of the patient¿s scalp.The reporter noticed it the morning of the report and there was a spot on the patient¿s head that had not healed.On the day of the report the scab peeled away and the lead wire could be seen.Follow-up information received from the healthcare provider (hcp) reported that there was an exposed wire at the top.The cause of the event was determined and not device related.The lead, extension, and implantable neurostimulator (ins) were all explanted.The patient recovered without permanent impairment and would be re-evaluated to see if she should be re-implanted.
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Concomitant product: product id 37602, serial # (b)(4), implanted: (b)(6) 2013, product type implantable neurostimulator; product id 3389s-40, lot # v297034, implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type lead; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type extension; product id 3389s-40, lot # v297034, implanted: (b)(6) 2009, explanted: (b)(6) 2015, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 7482a51, serial # (b)(4), implanted: (b)(6) 2010, product type extension.(b)(4).
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