B3: date is approximate.Year is confirmed valid.Section d references the main component of the system.Other medical products in use during the event include: brand name intellis; product id 97755, serial: (b)(6), product type: 0213-recharger medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Information was received from a patient regarding an external device. the reason for call was patient stated the recharger was getting really hot right above where the cord went into the paddle.Patient said 2 nights ago they reached back where the cord was getting hot and started smelling like a burning smell, almost smelled like a wires burning.Patient then said they pulled their hand back and noticed some sort of bluish color coming out of there or something.Patient also said they started to have an issue with the cord starting earlier this week, probably sunday where the cord stopped wanting to connect.The issue was not resolved.An email was sent to the repair department to replace the recharger.
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