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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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| Model Number 97715 |
| Device Problems
Energy Output Problem (1431); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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| Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Malaise (2359)
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| Event Date 08/01/2018 |
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Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 97755, serial# (b)(4), product type: recharger.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 with an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient met with a manufacturer representative (rep) on (b)(6) 2018 and since then their charge did not last very long.The ins had gone dead a couple of times.The patient stated the previous day they charged to 100% at 11 and by 4am they were in pain.They stated even before the meeting with the rep, the charge did not last for more then 2 days.They stated after implant they recharged twice a week, then it went to every 2 days and after the reprograming it did not last 24 hours.The patient explained that on (b)(6) 2018 they got sick and the next day they were hurting.They checked the ins and it was dead so they charged it.They then woke up in the middle of the night and were hurting.They checked and it was down already.The patient also stated sometimes the controller went from excellent connection to poor to good without them moving.A replacement recharger was sent.The patient was redirected to a healthcare professional (hcp).No further patient complications were reported as a result of this event.
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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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Additional information received from a manufacturer's representative and a consumer.It was reported that the patient had a shorter charge interval than expected after adjusting the patient's settings to a lower level than the initially programmed levels.The patient was initially programmed at 600 hz on 12 electrodes and needed to charge every other day.The new programming changed the settings to a single cathode, 3.5ma and 50 hz; the energy check estimated an 8 day charge interval.3.5 days had passed since the updated programming (when the ins was 100% charged) and 30% charge was left on the ins.The representative was expecting this to be above 50% due to energy check estimates.Good/green impedances were observed during an impedance check and the ins was at 60% when they left the patient on tuesday after which the patient charged to 100%.The representative was planning on meeting the patient on (b)(6) 2018 and they were advised to check the patient's recharge statistics and confirm their controller charge levels to reconcile them against the patient's account of charging.No further complications reported.
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Manufacturer Narrative
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Concomitant medical products: product id 97755, serial# (b)(4), product type recharger.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 a manufacturer representative (rep) on 2018-oct-02.The caller reiterated the following issues of the ins not holding a charge/frequent recharging, recharge quality going from good to lost connection even with belt on and sitting in same position, a loss of therapy even though no change to position or environment, and when the patient presses any button (even decrease button) on the controller, stimulation will come back and the controller freezes.The patient will push the x button but the controller doesn't respond.During troubleshooting, the rep confirmed that the recharging interval is unexpected.The rep stated that the patient has two groups but has only been using one of them.The rep confirmed this via the tablet stimulation usage report.The patient hasn't changed the intensity at all since programming was changed last week.The settings for group (no adaptive stim) being used were: bipole on 7-8, 1000 pulse width, 60 rate, 5.5 ma, cycling 15 min on/15 min off, and the impedance on 7-8 pair is 860 ohms.The check energy shows an interval of 3.5 days.The rep was surprised since the interval was 8 days when they last checked it with these settings and this isn't what they've seen for patients with similar programming.Technical services was unable to explain the difference and indicated that with those settings, this patient's impedances, at this point in time that is what the calculated interval is.The rep indicated that the impedances were fine in the 600-900 ohms range.Technical services had the rep check reference electrodes 0, 5, 8 and 14 and saw similar pattern across all electrodes.The rep provided recharge statistics from the tablet as follows: metrics - excellent recharge quality, 100% average ending, 1 hour average recharge time, 22 hour average recharge interval.9/23 32 mins, charged to 100%, no progress bar/coupling info shown 9/23 1.8 hrs, 10-100%, excellent coupling 9/24 2 hr, 10-100%, excellent coupling 9/24 1.6 hrs, 20-100%, good coupling 9/25 56 mins, 20-60%, excellent coupling 9/25 54 mins, 40-90%, good coupling 9/25 32 mins, 90-100%, excellent coupling 9/28 1.6 hrs, 10-100%, excellent coupling 9/28 2 mins, 100%, no progress bar/coupling info shown 10/1 2.6 hrs, 20-100%, fair coupling current battery charge upon interrogation is80%.The rep indicated that the ins is no deeper than their previous device and the patient can feel it through the skin.The rep indicated they will likely adjust programming to increase recharge interval as the patient is fatigued with having to charge so often.Technical services reviewed using lower impedance electrode pairs and lowering the pulse width to conserve energy.Technical services suggested trying a different recharging practice (tight piece of clothing, different position) to help with fluctuating recharge quality, re-setting the battery pack to help with controller freezing and to have the patient try a new programming for a period of time and then to check the recharge statistics again to ensure recharging interval is aligning with most recent programming changes.Technical services reviewed that collecting the data file is not necessary at this time as the cycling is likely the cause of the stimulation going away and coming back and current recharging aligns with programming changes that were implemented last week.Technical services reviewed recharging is more efficient when the controller is allowed to go to "sleep" and recommend patient not constantly check controller.No further complications were reported/are anticipated.
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Manufacturer Narrative
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Continuation of d11: product id 97755 serial# (b)(4) product type recharger.Product id 97745 serial# (b)(4) product type programmer, patient.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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 and it was reported that there was continued difficulty finding successful programming for the patient that didn't result in a recharge burden.The patient was happy with their previous device.The patient averaged 2 hours to charge the ins with good to excellent coupling.They then stated that the controller would be fully charged, but would deplete before they could fully recharge the ins.They were programmer with bipole, 90 pw, 1000 rate, cycling 10 min on/10 min off with 2.3 day interval.They tried 200 pw, 600 rate with cycling and interval was still 2.3 days.An amplitude of 3 ma was not therapeutic, so the patient had to increase to 5 ma.Another bipole on the other lead had and interval of 3.9 days.The left lead was programmer to ++- and the right lead to --+.They used 200 pw, 600 rate, and cycling with 4.2 day interval and 5.2 days with 90pw, 1000 rate.It was then reported that the controller did not always beep when it showed that recharger needed attention.It was reviewed how to change audio settings.The caller stated if the issue with the controller charge continued they would consider trying the patient's battery pack in the rep controller.It was further reported that the ins was programmed to work for their pain level which led to the ins depleting unexpectedly.They turned it down to try and resolve the ins depleting unexpectedly, but it didn't cover their pain unless they were sedentary.They were working to resolve the issue.No further complications were reported or anticipated.
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