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Model Number 97702 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Electromagnetic Compatibility Problem (2927)
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Patient Problem
Electric Shock (2554)
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Event Date 03/11/2024 |
Event Type
malfunction
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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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Information was received from a health care provider (hcp) via a manufacturer representative (rep) regarding a patient with an impla ntable neurostimulator (ins).It was reported that the patient was messing up her electrical equipment at home, such as induction hobs, light switches, etc.It was noted that there no problems were reported a week prior.The device was set to 4+ 5- 6+ pw 330 rate 60 (1.3v).Impedances between 846 and 1286 ohms.Since 4 days prior, everything the patient does, she experiences electricity.The stimulation was now turned off.No cause was identified.The patient had an outpatient clinic visit scheduled for (b)(6) 2024.Issue was not yet resolved.
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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 from the manufacturer representative (rep) reporting that the patient reported the same symptoms at their visit on (b)(6) 2024 but nothing relevant was found.The issues being reported could not be repeated during the clinic visit.Cause was not identified but the assumption is that its more psychological than something concerning the ins.No actions were taken besides the clinic visit.The issue was resolved.
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Search Alerts/Recalls
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