(b)(4).This charger model was associated in a field correction.Manufacturer's evaluation: corrective and preventive action (capa) investigation was performed.Pocket heating 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.
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