Model Number 97714 |
Device Problems
Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Pain (1994); Discomfort (2330); Sleep Dysfunction (2517); Electric Shock (2554)
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Event Type
malfunction
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Manufacturer Narrative
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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 via manufacturer representative, regarding patient's implantable neurostimulator (ins).It was reported that patient reported that their system (prior to the normal ins replacement) had been causing them trouble/discomfort and shocking.Rep saw patient in may for reprogramming and believed everything was working fine at that time.Explanted ins had already been discarded and impedances were not checked intra-op although in post-op, check connectivity was performed and everything was fine.Patient didn't report any issues after surgery.Patient was not complaining of any stim issue prior to surgery but patient noted they had stim turned down low.
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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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Additional information was received from the patient.Patient reported the issue was first noted (b)(6) 2020.The circumstances that led to the event included more intense pain, the patient could not sleep, and lack of energy.The stimulator was reset with not much pain relief.
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Event Description
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Additional information was received from a consumer.Patient reported that they could not controller the power delivered.[illegible] it felt too strong.The patient mentioned that they had seen the implanting doctor regarding 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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Search Alerts/Recalls
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