During generator replacement surgery, the surgeon observed fluid in the lead insulation along with a hole in the tubing.The surgeon then explanted the vns system and indicated that the patient would be reimplanted at a later time to give the patient time to heal.The generator and lead were returned to manufacturer for analysis.Analysis of the generator was completed on (b)(4) 2014.The device performed according to functional specifications.Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.Analysis of the lead was completed on (b)(4) 2014.Abraded openings were noted on the outer silicone tubing and in the inner silicone tubing of the negative coil.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
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