MEDTRONIC NEUROMODULATION PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 37702 |
Device Problems
Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285)
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Patient Problems
Discomfort (2330); Electric Shock (2554)
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Event Type
malfunction
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Event Description
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Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for occipital nerve stimulation.It was reported that the patient had an mri scan against the official recommendation.After the scan the patient experienced a very uncomfortable shock sensation in the region of the head, when stimulation was turned on (amplitude around 1 v). the settings for the impedance measurement were: 0.25v/0.7v/1.5v/3.0v, 80s, 100hz.
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Manufacturer Narrative
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G2: netherlands.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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Manufacturer Narrative
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Concomitant medical products: product id: (b)(4), product type: lead, product id: (b)(4), product type: lead.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 manufacturer representative (rep).It was reported, that the event began the week of (b)(6) 2023 or the week before.The exact date was unknown.The serial number and implant date of the ins were not provided.They tried to perform impedance measurement, but even stimulation on the lowest amplitude, pulse width, and rate already caused shocking.The system was believed to have malfunctioned, due to the mri with a non-conditional mri safe occipital nerve stimulation (ons) system.The event was not resolved.The rep believed, the leads were short circuiting.And thus causing the shocking.
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Search Alerts/Recalls
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