MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Failure to Power Up (1476); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/16/2024 |
Event Type
malfunction
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Event Description
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Caller reports patient indicated his controller is not responding with any button press.Caller reports he is not with patient, patient had called him.Suggest taking out the li ion battery while its plugged into the wall outlet, check for light on the power supply and led on the controller.Suggest putting the li ion battery back into the controller while still plugged into the wall outlet, check for light on the power supply and led on the controller.Suggest checking the pins on the controller and charging cord.(b)(6) 2024 rpl 421414 rtg0559125 (rep): (follow up/additional info) controller won't turn on with lithium battery or without it and plugged, per rep.Ts processed replacement controller.
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Manufacturer Narrative
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Continuation of d10: product id 97745, serial# (b)(6), product type programmer, patient section d information references the main component of the system.Other relevant device(s) are: product id: 97745, serial/lot #: (b)(6) , udi#: (b)(4).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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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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