MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Failure to Interrogate (1332); Overheating of Device (1437); Communication or Transmission Problem (2896); Insufficient Information (3190)
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Patient Problem
Burning Sensation (2146)
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Event Date 03/10/2024 |
Event Type
malfunction
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Event Description
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Information was received from a patient regarding an external device.The reason for call was patient reported they were having trouble charging their implant and the issue began sunday.Patient reported they would get an error message and they would get no device found.Patient also stated the paddle got warm and almost hot where the cord went into the paddle.An email was sent to the repair department to replace the recharger.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Continuation of d10: product id (b)(4) serial# (b)(6) product type recharger h3:analysis of the (b)(4) recharger (rtm) (serial number (b)(6) revealed a no device found message.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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Event Description
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Patient weight obtained.
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Manufacturer Narrative
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Continuation of d10: product id 97755 lot# serial# (b)(6) implanted: explanted: product type 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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