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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
Use of Incorrect Control/Treatment Settings (1126); Display or Visual Feedback Problem (1184); Failure to Deliver Energy (1211); High impedance (1291); Failure to Interrogate (1332); Unintended Collision (1429); Energy Output Problem (1431); No Device Output (1435); Device Difficult to Program or Calibrate (1496); Battery Problem (2885); Communication or Transmission Problem (2896); Loss of Data (2903); Device Contamination with Chemical or Other Material (2944); Impedance Problem (2950); Therapeutic or Diagnostic Output Failure (3023); Patient Device Interaction Problem (4001)
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| Patient Problems
Pain (1994); Discomfort (2330); Inadequate Pain Relief (2388); Insufficient Information (4580)
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| Event Date 07/01/2019 |
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Event Type
Injury
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Event Description
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Information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that the patient reported a fall a couple of years ago and has quite a hard lump on her back.She reports that it was after this fall that the impedance issues began.As of 2019-jul-22, contact 7 was out of range.It was noted that in 2022, the patient had three out of range impedances.They programmed around the high impedances while the patient waited for a surgery date.The ins was switching off, this was seen whilst interrogating the system in clinic.They sent for an x-ray and had exploration at the ins site on (b)(6) 2024, possible loose connection.The rep was in the operating room supporting a system revision.The patient came in for a revision on (b)(6) 2024 due to out of range impedances on contacts 1,4,6 and 7; it was also reported that contacts 1,5,6, and 7 were high and out of range.Their lead was directly connected to the ins.Upon disconnecting the lead, there was some material/debris on the lead surface which was removed using a swab. the impedances were tested using a wireless external neurostimulator (wens) and confirmed to be back in range (except for contact 0).The surgeon connected the lead back into the original ins, but in port 8-15 which was previously plugged.The clinician programmer (clp) was used to disconnect from the wens and reconnect to the ins, where the impedances were checked through the ins and confirmed to be in range (except for 0).The session was ended and the surgeon finished the case.The device was retightened and it was closed. the healthcare provider (hcp) could successfully establish communication with the ins, before the revision, with the wens, during the revision, and again with the ins once the battery was connected to the new lead.However, during this second interrogation session with the ins, the hcp forced closed the app, without ending the session as intended. immediately post-op, when trying to interrogate the ins in recovery - the ins was detected, communication went up to 100 (the telemetry loading bar reached 100%), but then a 'system error - code-0x3bdf345a' came up on the screen.The rep saw system error every time they try and interrogate the ins; this happens when using both the manufacturer representative's (rep's) tablet and the clinician tablet. this prevents the rep from communicating with the ins and setting any stimulation programs.They knew that this could be due to the pds being in deep sleep, so they opened the pds application and tried again. they've tried the settings that they've been sent previously and it was still not working.Technical services responded that a system error means that the app encountered an unexpected error.Normally this error is handled by android by terminating the running application.They cannot determine what happened based on the code.The nature of the code is not always meaningful. they tried multiple times and could not connect.The patient programmer would connect, but the programs could not be updated so she could not turn on her therapy.There were no patient factors as to why they could not connect with the clp as it has previously connected to the ins twice that day with no issues. the patient was dismissed by the hospital but the ins was off.When the rep tried to use the patient controller(ptm), it seemed that the programmer was showing the old group (a and b, while the hcp set only group a).However, because the old group was set on a dismissed channel, the ptm immediately prompted the oor message.They were getting oor on group a so two additional programs were added in b and c to allow to reduce amplitude.Technical services noted that this indicates that the ins is still able to communicate with the ptm, however, somehow the new stimulation settings were not saved and the rep cannot communicate with the ins using the tablet. the rep saw the patient in the clinic on 2024-feb-05.They attempted to i nterrogate the device using three clp, having followed troubleshooting tips provided by technical services.'system error - code 0x193e6af8' was seen on the first attempt at 10:33, and 'system error - code 0x4169b438' seen on second interrogation attempt (10:38am).These errors were seen after the ins was detected and communication ran up to 100. they used the patient programmer to disable the ins and then enable.The ins then started to recharge as it showed it was too low to turn stimulation on.They charged for approximately 15 minutes until it went from red to green (approximately 30%).They then tried to interrogate again using the clp but saw the error code 'system error - code 0x193e6af8' at 11:11am.The rep disabled and enabled the device three times in total.They also unpaired and re-paired the programmer to the ins.The rep did notice that after the second disable/enable the battery charge for the ins did show at 60% (previously they charged up to 30%). all tablets were updated to the correct versions.They restarted all tablets and opened/closed patient data service (pds). patient now has no therapy and is in a lot of pain.The issue was not resolved at the time of the report.The patient was alive with no injury at the time of the report. additional information was received.It was reported that the cause of the system error code was not determined.The further actions taken to resolve the issue were that device logs and reports were sent to technical services in the us to be analyzed; the hcp is waiting for a response.The system error, communication issue, and the new settings not being saved were not resolved; they will wait for further instructions once the logs and reports have been analyzed by the us.This issue is unresolved and the patient is now without therapy and in a lot of pain.They plan to revise if the issues are continued.
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Manufacturer Narrative
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Continuation of d10: product id 977a1 lot# serial# unknown implanted: (b)(6) 2019 product type lead section d information references the main component of the system.Other relevant device(s) are: product id: 977a1, serial/lot #: unknown, b3.Date is month and year valid.G2.Foreign: united kingdom.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.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Correction: continuation of d10: product id 977a290 lot# va1z6xw037 implanted: (b)(6) 2019 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.Software versions confirmed for the rep¿s old and new tablets.All logs /session reports were sent to technical services.Regarding cause of the system error/programming, the ins had a power on reset during the theatre case.This has been identified by technical services.The issue has not been resolved.The us team are planning to develop some software to enable us to factory reset the ins.The customer has agreed to this.Regarding cause of the impedances, during the case on (b)(6) 2024, when the hcp removed the lead from the ins, there was material on the lead.This look to be white/ chalky in texture and was removed using a wet and dry swab.When the lead was reinserted into a wens, the impedances were back in range ¿ except for 0.Contact 0 impedance was out of range ¿ do not use >40000, the hcp used a wet and dry swab to try and resolve this, but it did not come back in range.No, 0 is still out of range and we cannot connect to the ins.
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Manufacturer Narrative
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Continuation of d10: product id a710, lot#/serial# unknown, product type software.Product id a710, lot# /serial# unknown, product type software.Product id 977a290, lot# va1z6xw037, implanted: (b)(6) 2019, product type lead.Product id a710, lot#/serial# unknown, product type software.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 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 manufacturer representative (rep) reporting that the cause of the stimulation being positional and not being able to go above 7.3 was intermittent changes in impedances, possible lead issue.Action taken was reprogramming on different groups to give options, although this has not been successful as patient was seeing ¿settings not available¿ oor warning and can no longer adjust amplitude.Issue was not resolved.Patient cannot increase amplitude to desired strength and will be discussed in a medtronic meeting with possible lead revision.
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Event Description
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Additional information was received.It was reported that it was noted from the provided session reports that the ¿device battery has depleted to the point of therapy unavailability in the time since the last session.¿, ¿device below programmed intensity (oor).¿, and ¿the device time has been changed in the last 30 days.Diagnostics may have inaccurate data from (b)(6) 2019 to (b)(6) 2019.¿ the impedance tables showed intermittent high and out of range (40,000 ohms) impedances.Additional information was received.It was reported that technical services has been waiting for the manufacturer representative (rep) to gather all the information.The case was summarized as follows.All impedances were fine after a new lead was put in channel 0-7 in 2019.In between 2019 and now ((b)(6) 2024) the same impedances as in 2018 turned to be out-of-range; contact 1, 4, 6 and sometimes 7.Last friday ((b)(6)) they took out the lead from the ins (to check the impedance issue) and discovered a white chalky substance on the lead.They cleaned the lead.The surgeon did not want to put the lead back in channel 0-7, but instead decided to put it in channel 8-15.All impedances were fine again, except for contact 0.They closed the patient and reprogrammed the ins on channel 8-15, closed the app properly and updates were correctly reported in the session report.This was the session report from timeslot 9:57.However, half an hour later (10:21) the healthcare provider (hcp) made another interrogation.During this interrogation session with the ins, the hcp had to force close the app, without ending the session as intended.When the rep tried to re-interrogate the intellis, once the telemetry loading bar reached 100%, the application prompted a ¿system error¿ message.This happened multiple times.This happens when using both their tablet and the clinician¿s tablet.For these interrogations however, session reports were still created.When checking these session reports, the old settin gs for channel 0-7 (before the update), were shown.The rep also tried to use the controller (ptm), but it seems that the programmer was showing the old group (a and b, while the hcp set only group a).However, because the old group was set on a dismissed channel (0-7), the ptm immediately prompted the oor message.This indicates to us that the ins is still able to communicate with the ptm, however, somehow 1) the new stimulation settings were not saved 2) the rep cannot communicate with the ins using the tablet.Knowing that this could be due to the pds being in deep sleep, the rep opened the pds application, tried again, but the ¿system error¿ code was prompted again.Suspecting that there was a problem with the tablet, the rep decided to interrogate the ins with her tablet.Same result observed: ¿system error¿ code was prompted.They restarted the tablet/restarted the app, tried to communicate using the communicator cable, but nothing helped.Because of that, the ins could not be interrogated.The patient was dismissed by the hospital (last friday february 2nd), with the ins off.Yesterday, (monday february 5th), the rep tried to use a ct900e tablet, but also this did not work.As a last resort option, technical services proposed to try the disable/enable option of the ptm multiple times.The rep tried to disable and enable the ins 3 times, but the error was still seen when they tried to interrogate with a tablet afterwards.The handset could not communicate at all.In general the patient experiences ptm/recharger (rtm) communication issues since the fall she had a few years ago.Regarding anything notable leading to this issue, it was noted that the patient experienced a fall a few years ago (unknown when exactly).She hit her back at the corner of a table.After the fall there was a big swelling at her back, although the ins is implanted at the front.However, since the fall the patient reported to experience communication issue with both the rtm and ptm now and then.Although this was the first time the hcp encountered the system error issue.The last session prior to seeing this issue was on the (b)(6) 2022.Unfortunately, there were no logs for this date on the tablet according to the rep.No validation error or other error codes were observed.They could interrogate the ins, the percentage bar got to 100%.After that the screen turned black and the system error was prompted.For every failed interrogation with the ins due to the system error, a session report was still created.Additional information was received.It was reported that the patient was booked back in for next monday ((b)(6) 2024 and they have requested that the team come back to them this week with next steps as this patient has no therapy.Additional information was received.It was reported that the logs indicate that the user switched the programmed electrodes from being on electrodes 0-7 to electrodes 8-15 as mentioned in e-mail.These changes were successfully programed to the ins.However, these programs are stored in volatile memory (not permanent memory) until an end session command is executed by the ins.The logs indicate that the clinician programmer (cp) application was unable to execute an end session command in this case.The ins reset itself with a power on reset (por) between these two sessions(between end of previous session and start of next session).Upon the next interrogation of the implant, the therapy program within the ins indicated that electrodes 0-7 were programmed, which is unexpected as electrodes 8-15 were previously programmed in the last session.This indicates that due to por has occurred, which caused the ins to revert to the previously programmed settings.Prior to the por occurring, the instrument memory in the device was successfully written down to non-volatile memory which stored information about the leads being used, indicating that the tip location of the lead was 8, which is out of sync with the electrode configurations stored in therapy settings (electrodes 0-7).The instrument memory being out of sync with the therapy data in this case is the root cause of this system error.They were able to reproduce this crash in demo mode by changing the instrument memory tip location to 8 while having the electrodes on 0-7.Additional information was received.It was reported that the cp app was unable to execute the end session command because it did not receive the response for the previous command from ins, due to that, the end session command was not sent to ins from cp app.They do not think they have any other way of recovering the ins apart from following the steps mentioned using lab programmer.Additional information was received.It was reported that the cause of the contact 0 impedance issue even after the revision was not determined.It was reported that someone from technical services was flying out today (2024-mar-27) with the tool (previously referenced as newly developed software) that has been created and they are seeing the patient tomorrow ( (b)(6) 2024) at the hospital to perform the factory reset.As previously shared, technical services successfully preformed a reset (the stimx tui application reset the ins which allowed interrogation using the clinician programmer app.Upon completion of the procedure, the ins was interrogated and was confirmed to be operating correctly) on thursday (b)(6) 2024.They were able to program the device to cover the patients pain symptoms.However, the lead impedance issues remained.They preformed multiple impedance measurements with intermittent high impedances as a result.They found 2 contacts that were within normal impedance range and these are currently used to provide therapy to the patient.Additional information was received.It was reported that the nurse saw the patient again yesterday ( (b)(6) 2024) as the patient called earlier in the week with problems.The pain in her back had gotten worse with the stimulation and it wasn't covering the pain as well as it did in the clinic.The nurse rechecked impedances and all were ok except no 8.They changed the settings several times including electrodes and pw (pulse width) / pr (pulse rate).They kept rechecking impedances and each time after the initial check they were all in range.The nurse managed to cover the index pain with only a mild affect to her back which was manageable.The handset also let her increase and decrease amplitude.She went home with 2 programs again in case the handset stopped her increasing and the nurse arranged a call this morning ((b)(6) 2024).Unfortunately the patient is still having trouble with back pain.The stimulation effect is also very positional and the handset now will not let her go above 7.3, but she needed it higher when walking.The nurse was not sure there are any programming options left and wondered what the rep thought.The nurse has a further telephone follow-up in 3 weeks but wondered whether the main option now is revision or if there is anything else to try.The nurse wanted to check before they spoke to consultants about her.They had reduced the pw and pr again as this seemed to contribute to the back discomfort / pain.
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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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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 manufacturer representative (rep).It was reported that the rep saw the patient last week, she was reprogrammed and is still awaiting a decision from the manufacturer.
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