MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Patient Device Interaction Problem (4001)
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Patient Problems
Device Overstimulation of Tissue (1991); Sleep Dysfunction (2517)
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Event Date 11/16/2023 |
Event Type
malfunction
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Manufacturer Narrative
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B3: date is approximate.Month and year are confirmed valid.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 friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.The reason for call was caller stated the patient texted with a manufacturer representative (rep) this morning and told them to call for a new controller to be sent.Caller stated the stimulation is erratic, sometimes there is no stim, sometimes there is too much stim.Caller states when patient is laying down the stimulation will go from no stimulation to too much stimulation and patient can't sleep at night.Patient was asked caller if patient has had any recent falls or trauma and caller states no.Caller states the pt has been using one program during the day and another at night and they can control the intensity up and down but last night when they went to use the sleep program it felt like the nerves were being overstimulated.Pt doesn't change positions when the issue happens.Agent reviewed device function.Patient got on the line, demanded a new controller, and wanted agent to call the rep.The patient was redirected to their healthcare provider to further address the issue.Agent sent email to rep.
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Event Description
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Additional information from the rep indciated that they reprogrammed adaptive stim so where she isn¿t tingling in a flat position.The issue was resolved.Patient weight is unknown.
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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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