Boston scientific neuromodulation (bsn) received information about an event on (b)(6) 2013, that would have been reportable under 21 cfr 803, medical device reporting within our complaint system.However, the issue reported was related to a medtronic ipg.The information received stated that the patient's medtronic ipg was explanted due to charging difficulties.The explant occurred at calloway creek surgery center.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
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