MEDTRONIC NEUROMODULATION EXTERNAL NEUROSTIMULATOR; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
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Model Number NEU_ENS_STIMULATOR |
Device Problems
Break (1069); Activation, Positioning or Separation Problem (2906); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2024 |
Event Type
malfunction
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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: 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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It was reported that healthcare provider (hcp) had a lot of difficulty getting the screw to drill.Screw head stripped during insertion process.A lot of pressure needed to be applied to the screw to get it to screw into the bone.Had to apply excessive force.Stated she was worried with this level of force the screw could skive.Also a lot of pressure when at a difficult angle, making it hard to screw at the trajectory of the bhd guide.Surgeon complained it was really hurting her hand and wrist with the amount of pressure she was having to apply.Hcp troubleshooted to see if there was a better screw that could be used. screw stayed in place, did not remove as risk higher than the benefit of moving.The issue was not resolved.No symptoms reported.
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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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Event Description
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Additional information was received stating that the cause of the burr hole screw issues were not determined.Seems to be a wide spread issue amongst the field.The issue has not been resolved.
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Search Alerts/Recalls
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