Model Number 37612 |
Device Problems
Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885); Communication or Transmission Problem (2896)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Date is approximate.Month and year are confirmed valid.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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Information was received from a manufacturer's representative (rep) regarding an implantable neurostimulator (ins).The reason for call was caller stated ins has been off for over a year and is in overdischarge.Caller requested assistance starting physician recharge mode, as they've only "done it once before".Caller stated patient had an appointment with healthcare provider (hcp) either last week or a couple weeks ago and it was discovered at that appointment that the ins wouldn't connect to the tablet and patient confirmed with their equipment when they got home.Tech services (tss) walked caller through initiating prm with wireless recharger.Tss reviewed next steps for bringing ins out of overdischarge once it starts to charge normally and that multiple prms may be needed.No symptoms reported.
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Event Description
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Additional information received from the manufacturer¿s representative (rep) reported the cause of the overdischarge was due to the patient having a slight cognitive decline and forgetting to charge.A physician mode recharge was performed which resolved the issue.
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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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Search Alerts/Recalls
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