MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Energy Output Problem (1431); Charging Problem (2892)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 05/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 97745, serial# unknown, product type programmer, patient.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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Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain indications.Caller (mdt rep) reports per patient's husband, that every time she makes an adjustment the ins doesn't respond, or the controller skips some parameters and the patient can sometimes get too much stimulation.Patient was currently under anesthesia to get more information on the current issue.Caller reported seeing the patient on (b)(6), 2022 and patient did not report the issue so the assumption it has been occurring since then.Patient had a pocket revision today to move ins location.The reason for revision was elective (per caller) the patient wanted more lateral for recharging.We discussed having patient explain or show mdt rep what was occurring to get a better understanding of when and what was occurring.Caller (mdt rep) reported per patient's husband, the patient cannot charge past 70% charge.Caller to run some diagnostics on the patient's ins after the patient recovers from an elective pocket revision.
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Event Description
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Rep reported they did try disabling and re-enabling it in case it was stuck in passive recharge mode to try to resolve 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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