Model Number 97715 |
Device Problems
Intermittent Continuity (1121); Failure to Deliver Energy (1211); Data Problem (3196); Patient Device Interaction Problem (4001)
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Patient Problems
Irritability (2421); Sleep Dysfunction (2517)
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Event Date 01/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Event date month and year valid ((b)(6) 2021).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient had issues with their stimulation "going on and off".They stated that they would set their stimulation to where they preferred it to be and then "it starts going on and off".The past night ((b)(6) 2021), before going to sleep, they turned it down and then the stimulation turned back up on its own.They also stated that they couldn't sleep because it was very irritating.The patient confirmed that adaptive stimulation was turned off.The issue was not resolved.The patient was redirected to their healthcare provider to further address the issue.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Patient reported that stimulator kept cut on & off stimulation.Nothing was changed.Patient was told could not be helped over phone.Patient voiced their dissatisfaction.
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Event Description
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Additional information was received from the patient.It was reported that since implant, they noticed when they move or "turn the wrong way" the patient's therapy changed to a different setting or turned off.The patient also reported that on monday, therapy shut off without the patient turning off the therapy again.Additional information was received from the manufacturer representative (rep).The rep noted they were not an employee at this time and would be unaware of this specific event.Additional information was received from the manufacturer representative (rep).It was reported that the patient was seen on (b)(6) 2019 and (b)(6) 2020 and there were not notes about the device changing settings randomly or turning off by itself.No additional reps that may have information on this at this time.
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Manufacturer Narrative
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Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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