(b)(4).This charger model was associated with a field correction.Corrective and preventive action (capa) investigation was performed.Pocket heating was confirmed.The investigation for capa (b)(4) associated with heating while charging (pocket heating) concluded that the charger was capable of transferring energy to the ipg at a rate that would cause heating of the ipg and/or charging wand of sufficient elevated temperature to cause pain and burns.The heating while charging was determined to be exacerbated by off-axis charging of shallow implanted ipgs and that all chargers were capable of elevated heating.Sjm has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Sjm defers to the patient's physician regarding medical history.
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