MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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Model Number 97715 |
Device Problems
Display or Visual Feedback Problem (1184); Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Migration or Expulsion of Device (1395); Failure to Power Up (1476); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Electromagnetic Compatibility Problem (2927); Material Integrity Problem (2978); Operating System Becomes Nonfunctional (2996); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
Injury
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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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It was reported that patient was having surgery on the 24th because the device inside of them had moved from where it was implanted.Pss asked event date, but pt did not give a date and said "you should have it on record", and said they didn't have the paperwork with them.
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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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Clarifying information was received from the patient.Itwas reported that the patient had surgery on (b)(6) 2021 and they had to move the implantable neurostimulator.The patient stated that the implantable neurostimulator was right on top of disks that they had to fix.The patient stated that l5 down to s1 had slipped and went down, so they had to fix the first disk.The patient noted that the stimulation had cut off on him by itself on (b)(6) 2021 - the patient noted that the battery was somewhere around 30% charged.It was reviewed with the patient that the therapy will shut off when the battery goes below a certain percentage because it does not have the power to provide therapy needed.The patient was able to connect to recharge, but then it stopped.The patient has a bandage over the implantable neurostimulator site.It was reviewed with the patient that swelling and the bandage at the implantable neurostimulator site are likely causing issues with telemetry during recharge which should improve when he has healed more.The patient was redirect to their health care professional to further address the issue.
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Event Description
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Additional information received reported that the patient had an accident last night with their dog and deer in their yard and the c ontroller was pulled and fell and broke, the screen was cracked in pieces.Patient mentioned they received the recharger.An email was sent to the repair department to replace the controller device.During a call, pt mentioned they had an ankle bracelet and the pt thought the ankle bracelet could be interfering with the spinal cord stimulator(scs).Pt said the scs "screws with them and fucks up and does not do what it was supposed to" since about june 26.Pt did not know if ankle bracelet did or did not interfere with scs.Pt referenced leads moving and having to have disc surgery to repair discs in back: pt mentioned the leads in spine were on top of the discs that needed to be fixed, so hcp moved the leads to successfully fix discs; disc surgery was performed on june 24.During a call, pt mentioned they had a tooth surgically removed on 24 june and the pt thought the dental environment could have interfered with the spinal cord stimulator(scs) since 26 june.Pt did not know if dental environment did pt did or did not interfere with scs.Pt also mentioned having two additional teeth pulled today.The reason for call was pt states their ins was just moved inside and had an ankle bracelet on and cannot charge self up.Pt states they could charge their controller but not the ins.Pt states the controller was blank and would not turn on.Troubleshooting was unable to be performed as pt was driving to dentist and could not troubleshoot.Pt reiterated details of case.During the call, pt attempted to initiate a charging session of the implanted neurostimulator(ins), but controller went blank/unresponsive.Pt performed a hard reset of the controller and successfully initiated a charging session with "excellent" charging quality.Charge quality was switching between "excellent" and "good." ins charge was in the orange and controller charge was 90%.The issue was not resolved.An email was sent to the repair department to replace the recharger antenna.
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Manufacturer Narrative
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Continuation of d10: product id 97755 lot# serial# (b)(6) : product type recharger product id 97745 lot# serial# (b)(6) product type programmer, patient product id neu_unknown_lead lot# serial# unknown 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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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.The patient (pt) called back and reported that they got the replacement controller bonded with their implantable neurostimulator (ins) and they were actively recharging the ins.Pt noted that since charging the ins, the controller battery has dropped from 80-60% but the ins is still displaying a red battery, which was reviewed.Pt confirmed that they saw their name on the lock screen and inquired about changing the date/time, which was also reviewed.Reviewed best practice when it came to charging the ins.Pt noted during the call that they fell this morning, but the pt indicated that this was due to them not having access to their therapy yet (the pt's ins was depleted and needed to be charged).
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Manufacturer Narrative
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Continuation of d10: product id: 97755; lot#serial#: (b)(6); product type: recharger; product id: 97745; lot#serial#: (b)(6); product type: programmer, patient; product id: 977c165; lot#: va1sjt9021; 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.
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Search Alerts/Recalls
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