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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
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| Model Number 97715 |
| Device Problems
Electromagnetic Interference (1194); Failure to Deliver Energy (1211); Delayed Charge Time (2586); Charging Problem (2892); Communication or Transmission Problem (2896)
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| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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| Event Date 04/26/2021 |
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id 97755 lot# serial# (b)(4) implanted: explanted: product type recharger product id 97745 lot# serial# (b)(4) implanted: explanted: product type programmer.Patient 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 patient (pt) regarding an implantable neurostimulator (ins).Patient reported the implant is shutting itself off since 3 weeks ago when ins is charged up.The patient was redirected to their healthcare provider to further address the issue.Patient stated rep was aware of the issue since 3 weeks ago and rep explained department store security gates could turn therapy off.Patient services (ps) reviewed it is recommended for patients to carry their controller with them to check therapy setting if necessary. information was received from a patient (pt) regarding an external device.The reason for call was patient reported since 3 weeks ago they are having difficulty charging the implant, they get reposition recharger, can't find device, poor and good recharging quality and software problem on thursday or friday but they cannot recall all the information under software problem.Patient stated the implant will not charge past 50% and it takes forever to charge the implant.Patient services (ps) asked if there was damage on the recharger (rtm) and patient said no.Ps confirmed recharger (rtm) does not get hot when recharging the implant.Patient stated the controller showed ins 50% and ins 50% charged.The issue was not resolved.No symptoms or patient complications were reported.Additional information received reported pt called back and reported they were still having issues charging the ins battery.Pt stated that during recharge they would have issues connecting to the ins and then when connected it will show "charge finished" when the ins is only @ 40%.
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Manufacturer Narrative
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Continuation of d10: product id: 97755, serial# (b)(6), and product type: recharger.Product id: 97745, serial# (b)(6), and 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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Additional information from the manufacturing representative (rep) indicated that the patient sent a text message indicating that they attempted to charge and the ins battery would not increment up past 60% and in the morning the ins had turned off.The caller did not have any other details.Technical services reviewed considerations for troubleshooting.The caller indicated that they will follow up with the patient and may set an appointment to meet with them.
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Event Description
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Additional information received reported patient called back stating that their stimulation turned off this morning on its own, patient said that they were able to turn the stimulation back on.Patient said that this was the third time that this had occurred.Patient had reset the controller but the stimulation still turned itself off on its own.Patient had met with a representative who ran a diagnostic of their implant showing when the stimulation turned off by itself.Patient had received a new controller for their old controller was slow to charge.Patient was redirected back to their medtronic representative regarding this issue.
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Manufacturer Narrative
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Concomitant medical products: product id 97755, lot#/serial# (b)(6).Product type recharger product id 97745, lot#/serial# (b)(6), 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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Manufacturer Narrative
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Continuation of d10: product id 97755, serial# (b)(6), product type: recharger; product id 97745, serial# (b)(6), 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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The rep reported on 06-17 while she was with patient.They are reporting the same information as before.The rep noted that based on data provided today, they believe the ins was depleting when the patient isn't expecting it to.They had been asked to create a diary of the times battery shows off on the controller and based on that information and information provided by the recharging stats, 3 of those dates correspond with days stim was reported to be off.Once mdt file and session reports are received, technical services will evaluate and follow up with rep and patient.Rep will be calling mobility to have those reports pulled.Sent email to rep so she knows which reports are needed.
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Event Description
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Additional information was received from the rep and it was reported that the caller was following up on the situation with the ins turning off.The patient was having difficulty charging the ins, the caller indicated that the patient received a new controller and recharger and that resolved any issues previous reported.The caller indicated that the patient is still experiencing the ins turning off in the middle of the night.The caller reviewed the following information from the stimulation usage graph: the overall device usage shows 76%.The stim usage graph shows on 5/8 the ins depleted and turned off and then 5/9 0% usage and on 5/10 usage is 90%.5/17 stim turns off because the ins was depleted 5/20 stim turns off because the ins was depleted 5/22 stim turns off because the ins was depleted and stim was on for 45% of the day , 5/23 stim was on 5/27 stim turns off because the ins was depleted and stim was on for 80% of the day, stim was on for 40% of 5/29 and then on for 5 days without turning off the caller provided the information from the recharge diary: the average recharging interval was 1 day and average recharger percentage was 40%.The caller provided recharge information from a session on 5/22 - 1 hour charging with fair coupling started at 10% to 40% the patient claims that it is taking a long time to charge the ins so that is why they don't charge it completely.The patient also indicates that the they are shifting when charging and moving, the patient described one session in which she stayed in the prone position to try to charge.The caller ran a recharge interval calculation with the group used by the patient for therapy and the result was 2.6 days.The caller stated that they reviewed how to get better coupling during a charging session and the patient will try to improve the charging efficiency.The caller indicated that they will re-evaluate the situation after more attempt to charge.
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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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