MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Battery Problem (2885); Loss of Data (2903); Data Problem (3196)
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Patient Problems
Device Overstimulation of Tissue (1991); Dyskinesia (2363); Electric Shock (2554)
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Event Date 12/02/2021 |
Event Type
malfunction
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Event Description
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Information was received from a patient who was implanted with an implantable neurostimulator (ins) for spinal pain indications.It was reported that the patient (pt) stated their ins had been acting funny, and it's started all in the last 6 months.Pt said they went through airport security and turned their ins off, then turned the ins back on afterwards.However pt said while walking to their gate, they got a serious jolt and couldn't move so their partner had to use the controller to turn stimulation down.Pt mentioned when they checked the intensity, the settings was on "28" or something.Pt then said a couple times the battery would say it was empty, but when they went to charge the ins, the battery would show as full.Pt said they had mentioned this to their healthcare provider (hcp) and rep on april 13th when pt went in for programming (pt said the hcp wanted ins programmed as pt was charging every 3 days - which pt said they didn't mind because the therapy was working - and pt mentioned dtm programming).Pt said they have tried resetting controller (nld093448n).Pt then said 2 days ago the ins kept turning off while trying to charge.Pt said the ins battery was at 40% so they turned stim on and the intensity level was correct at that time, but 20 mins later they checked and the controller would say stim was off and pt said they turned stim back on, but the settings were all at 0.Pt said they kept having to turn stim back on while charging as stim kept turning off.Pt did not see any damage to controller battery compartment.The patient was redirected to their healthcare provider to check ins and further address the issue.Additional information was received from the rep on 2022-jun-29.It was reported that the cause was not determined.The issue could not be reproduced and confirmed to have occurred only that one time.Rep checked the stimulator, programmer, and charger, and everything was working fine and no issues were noted.
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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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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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Pt said they first started programming for cycling about a year ago with rep and then called in (confirmed issues documented in this case) about numbers all going to 0.Pt said it had happened twice before calling in and pt reset controller like rep had told them to do in the past should anything happen and pt said stim finally came back on and was working.Pt said they met with the rep and then the issue happened again and rep noticed the programming they did the last time wasn't in there at all so the rep had to redo programming again for the "positional thing" and because pt was charging a lot.Pt met with rep at their last appointment on wednesday.Pss documented information given during the call.
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Search Alerts/Recalls
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