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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
Intermittent Continuity (1121); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); High impedance (1291); Low impedance (2285); Battery Problem (2885); Insufficient Information (3190); Data Problem (3196)
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| Patient Problem
Pain (1994)
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| Event Date 02/19/2024 |
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Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id 977a290 lot# serial# unknown implanted: (b)(6) 2020 explanted: product type lead b3: date is valid.G2.Foreign: switzerland 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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that a patient came to see us because he couldn't feel anything, and the pain had returned.At the check-up, plots 2 and 3 were above 40000, they were being used and the nurses had lowered one peg.The patient came back a little later in the day because he said that the intensity was increasing on its own without doing anything.After checkup plots 2 and 3 above 40000.The patient¿s programming was increased from 300 to 410 to avoid increasing the intensity by more than 2.Unknown if the issue resolved.Additional information was received.Cause of the high impedance was not known, regarding the intensity increasing on its own, the patient came back because their pain had returned, the nurse checked the impedances and found that the studs used were not up to standard, so they changed studs to get the same coverage for the pain.The impedance began to increase, and the patient felt nothing, but from 2ma the intensity became too strong.Below 2ma, the patient felt nothing, even when they moved their head.They stated that the intensity rises by itself.Adaptive stim was not being used.To resolve, on the 2023-feb-19 reduction of pulse width (pw), intensity blocked at 2ma on the programming tablet to prevent the patient from feeling intensities that are too high.For the moment, the issue has resolved.Additionally, technical services (ts) stated that in addition to the presence of an open circuit at points 2 and 3, ts noticed something else.Although they are in range, ts found it rather strange that 0 and 1 share the same 'value' with electrodes 4 and 5.Also, 4 is programmed as the cathode.Ts can't rule out that, in addition to the open circuit at points 2 and 3, this probe has a combination of open circuit and short circuit, or a fluid short that affects the other electrodes.This could cause a leakage of electricity somewhere, which the patient perceives as a 'spontaneous' increase in stimulation, even though the stimulation was still the same (in terms of output).As was mentioned, the cervical region is quite delicate as it is subject to a wide range of movements, which subjects the probe to a certain degree of mechanical stress, which could lead to significant fracture of the conductor.In view of the above, the doctor might consider continuing to try and find other electrodes to give good stimulation to the patient without the negative effects.If nothing works, they may consider revising the lead.The lead showed an impedance value of >40000 for multiple electrodes.Additional information was received.It was confirmed that when the rep was talking about ¿studs¿, they were talking about the lead on the electrodes.Regarding the statement ¿changed studs¿, it was confirmed that the patient was reprogrammed, no lead explant was done.No further appointments have been scheduled because the patient has been relieved of their pain.The issue has currently resolved.Information confirmed with physician/account.
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Manufacturer Narrative
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Continuation of d10: product id 977a290, lot# serial# unknown, implanted: (b)(6) 2020, 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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Event Description
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Additional information was received from the healthcare provider (hcp) and the manufacturer representative (rep).It was reported that the patient had came back and they checked the program on a on b on c and as soon as they pass 2 of intensity the patient feels that it goes up by itself but at 1.8-1.9 feels really very little but no spontaneous increase.It was a cervical electrode fitted on 22.05.20 on an ins 28.05.20.Technical services also noted that the mdt data report did not show anything strange.From the data it was seen that the patient was turning often the stimulation on and off, and changing group using the controller, probably with the intent to mitigate the side effects.The rep saw the patient "yesterday", (b)(6) 2024, again because he had to cut off his stimulation since his last appointment because his remote control went from 1ma to 4 on its own.The rep sent a video, and the patient also took pictures of error messages on his remote.The video was made on february 21.The rep took over his programming and put 2 groups, 1 in ld and the other in hd.The rep also changed his remote and gave him a new one to see if the problem returned.The patient didn't call the rep back to tell them that the problem was coming back.The rep is going to send the remote back for analysis.Technical services replied that the 4 indicates the program number of the group, not an involuntary change in stimulation.They see that in group b, the program 1 is active and not the 4.Please ask the patient to do the same test, and see if now the number goes from 2.9ma to 1 (active program number).Screen 42 shows the last error reported by the controller.The last reported error was d0n2 (8- 2 fev 2024, 20:13; 9- 81, 10- d0n2, 11-).This code indicates that the ins was discharged and processing was not available.This diagnostic code warns the user that their ins needs to be recharged.The other picture appears to be an image of the ins information screen.The rep put the groups back in order and the p4 was moved to the p1.The rep noted that this does not explain why the remote control went from 1 to 4 without having manipulated it and asked if there was something wrong with the medtronic data report.From the video, technical services saw the following: the programmer shows initially 1.5, which corresponds to the amplitude of the program 4, and then a 4 which indicates the number of the program (p4).This is how the programmer is designed to work.For example, if the program active was the 1, then we expect that the programmer will show first 1.5 and then 1 (see video attached).In the second video you can see how the numbering will change when programming all 4 programs, and giving the option to change the stimulation to all programs at the same time.They didn¿t find anything strange in the mdt data.The out of range impedances of >40,000 ohms were also listed as "do not use" and the high, but in range impedances were listed as "avoid" on the session report.Additional information was received from a manufacturer representative (rep).It was reported that the rep thinks the patient had a problem with his remote control, as the screen was becoming transparent.However, since the new remote control was installed, there seems to have been no p roblem.The rep had never seen a group with only program 4 active, and that's what made them doubt.Since the rep has reprogrammed everything to p1, the patient shouldn't have any more problems.To clarify the "transparent screen", the rep said that when they switched off the remote control, the screen froze and did not go to standby.They i don't know if the screen is liquid crystal, but the home screen remained overprinted.The colors were gone, but they could see the screen mask (all the details of the remote control without the colors).Additional information was received.It was reported that the patient perceived stimulation increases on its own.From the provided session reports, it was noted that the device time had been changed in the last 30 days and the diagnostic data may be inaccurate between feb 19, 2023 and feb 19, 2024.The session reports also noted that adaptivestim was not configured.The session report also noted that 0, 1, 2, and 3 were out of range.The time of the device is shifted by more then 90 minutes compared to the programmer.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information was received from the rep reporting that the cause of the patient's intensity "feels that it goes up by itself" determined in principle was a misinterpretation.Of the active group, only program 4 was active.When the patient turned on his remote control, the screen showed program 1 and then program 4.The issue of seems like stim goes up on it's own, screen/display issues has been resolved.The patient was called to find out if this has happened since the remote control was changed, and he no longer has any problems.Everything has been sorted out.It was noted the patient had a defective screen.
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Search Alerts/Recalls
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