| Model Number 97714 |
| Device Problems
Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Insufficient Information (3190)
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| Patient Problems
Undesired Nerve Stimulation (1980); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Electric Shock (2554)
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| Event Date 07/14/2016 |
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Event Type
malfunction
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Event Description
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Information was received from a consumer regarding a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient was seeking help for someone ¿messing her up.¿ the patient had a battery replacement in 2016.Additional information was received from the consumer on 2017-03-07 reporting that the product was the problem.It was noted that the patient had been promised that the new battery and leads would work fine.It was reported that the leads were not replaced because they would not reach the pain area.It was noted that the patient had only found that out pre-operative for the surgery where the manufacturer representative and health care professional (hcp) were there.It was noted that the patient had returned several times to have the manufacturer representative program the device but they were never able to get the coverage that the patient had before they went in for the replacement.It was reported that the patient had the new battery and old leads implanted but they ¿serve no purpose¿ as ¿nothing was working.¿ the patient reported that they believed that their implant was one of the peripheral implants that was subject to a previous lawsuit which currently caused the patient¿s insurance to not cover the replacement.Additional information was received from the consumer on 2017-03-24 reporting that in (b)(6) 2010 the health care professional (hcp) put in the peripheral stimulator for chronic scapula pain that the patient had suffered with for years.After (b)(6), a manufacturer representative and another health care professional (hcp) made adjustments to the implant.All of the settings were reported to be wonderful but did not provide total relief from the patient¿s pain.It was enough relief that the patient could go about their life.Between the pain medication and the implant the patient had a much better quality of life.It was reported that the patient never had to return or have any adjustments to the implant.It was noted that even at home after years with the implant the patient never had to change the settings.The patient noted that this was the best they had felt in years.The patient¿s original hcp was no longer practicing in that state and so that patient found a new hcp.A consult was performed about replacing the battery.After speaking with this new hcp and a manufacturer representative it was reported that the new battery would be mri compatible and would have other new technology that the existing battery did not have.It was decided to do x-rays to determine the location of the leads.After seeing the peripheral implant the hcp and manufacturer representative were unsure if the replacement could be done.The patient reported that the reason that they were even consulting about a replacement was because the battery life was 7-9 years when they were using it a couple of hours per day.The patient had been using it since 2010 for 24 hours per day and 7 days per week.After a few days it was determined that they could make it work and change out the battery and the leads.The surgery was explained to the patient and the paperwork was sent to insurance.This paperwork showed that the leads would be changed and the battery would not be.The patient questioned this and was told that the leads and battery would be changed out with insurance approval.It was reported that a call was received 4 weeks after the last appointment.The insurance approved the battery and lead change.The surgery was scheduled for (b)(6) 2016.During the prep for surgery the patient and hcp discussed how both the battery and leads would be replaced.The health care professional (hcp) then consulted with the manufacturer representative.They looked at the x-rays and stated that the implant would not be mri compatible because of it being ¿peripheral¿ and not spinal also the new leads would cover a much smaller area than the old leads.The new leads were shorter and would therefore not reach the pain in the scapula.Since the patient was already prepped and needed the new battery they agreed to just get the new battery put in.After the replacement surgery the manufacturer representative saw the patient to program it.It was noted that during this session the patient had just come from surgery and so was on 2 percocet of 325 mg.It was noted that the manufacturer representative was ¿messing around with the programmer¿ and the patient could not really feel the implant working at all as they were on pain medication.The patient returned server time to see the hcp and manufacturer representative.Each time they tried program the patient to get relief to where it was before the battery replacement was it never happened.It was reported that the patient was in more pain that they ever had been before the battery replacement.More x-rays were taken to see if the leads had moved but the hcp said that they had not moved.After weeks of returning and more pain with the hcp and manufacturer representative ¿getting nowhere,¿ the patient needed to find a new hcp and the manufacturer representative could not figure out why the patient was not getting any relief let alone the relief level that they had been before the battery replacement.Insurance denied having the leads replaced.It was reported that the patient was in tremendous pain and receiving 30 mg of oxycodone per day when the patient did not want to be on pain medications.It was noted that with this pain medication it was enough to allow them to function and work with a functioning implant.It was reported that the patient was messed up with an implant that did nothing for the as the implant was in their left buttock and the leads were up to their scapula but did not reach the same area as before the surgery.The patient reported that they had been told that the implant could be removed.The patient reported that they had pain and were suffering due to being misled into thinking that they could have the new battery and new leads to adjust to positions and be mri compatible.The patient stated that in summary they were in much more pain than before the battery replacement, the new battery only lasted 2 days and needed to recharge overnight, the patient was only using it so that no one could tell them that they did not give it a chance, it gave them no relief, it ¿shocks¿ them near their ribs which was nowhere near their scapula, ¿the device [was in the patient] for no reason now,¿ the patient¿s life quality was worse than before the battery replacement, and that the hcp and manufacturer representative did not realize when they saw the x-rays during the original consult that it was peripheral and that the new ¿shorter¿ leads would not be long enough to reach the patient¿s pain in their scapula.No further com plications were reported.
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Manufacturer Narrative
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Information reported in supplemental mdr 001 regarding the patient feeling that the ins may be near end of life (eol) and the replacement performed on (b)(6) 2016 applies to mdr# 3004209178-2017-08459.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).The hcp reported that the patient first started experiencing the symptoms on (b)(6) 2016.It was reported that the patient was not feeling stimulation being covered, even though the leads were not moved during the procedure.No further complications are anticipated.
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: 3777-60, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.Product id: 3777-60, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.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).The hcp reported that the patient first started experiencing the symptoms on (b)(6) 2016.The hcp stated that the patient felt the battery may be near end of life (eol).The patient had the ins explanted on (b)(6) 2016.It was reported that the patient was not feeling stimulation being covered, even though the leads were not moved during the procedure.No further complications are anticipated.
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Manufacturer Narrative
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Please disregard the event summaries of the previous report.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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Product event summary #(not working): evaluation determined that investigation is needed because it was reported that it was not working and was shocking the patient at their ribs which was not near where they needed pain relief in their scapula.The reported information is an allegation that suggests a possible failure of a device, labeling, or packaging to meet specifications.An assessment of the source information indicates a potential relationship between the adverse event(s) reported and the alleged device failure.Assessment determined that there is not an existing formal investigation for the issue identified in this event.However, a new formal investigation is not possible, because there is inadequate information to initiate formal investigation activities and the most likely cause cannot be determined; the cause of why the replacement battery with the old leads were not working, not providing pain relief, and shocking in their ribs remains undetermined.Follow-up for more information is pending a response from the legal department due to the potential for a legal claim.(shocking): evaluation determined that investigation is needed because it was reported that the patient was getting shocked in their ribs.The reported information is an allegation that suggests a possible failure of a device, labeling, or packaging to meet specifications.An assessment of the source information indicates a potential relationship between the adverse event(s) reported and the alleged device failure.Assessment determined that there is not an existing formal investigation for the issue identified in this event.However, a new formal investigation is not needed because the issue identified in this event is a known inherent risk as disclosed in product labeling, and additional investigation is not needed.Supporting event information used to determine the issue was a known event includes the report that the patient was being shocked in their ribs.Concomitant medical products: product id: 3777-60, serial# (b)(4), implanted: (b)(6) 2010, product type: lead.Product id: 3777-60, serial# (b)(4)implanted: (b)(6) 2010, product type: lead.
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Event Description
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The weight of the patient at the time of the event was reported.
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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 was received from a patient on 2017-jun-19.The patient stated that they have another medical issue that their implant, which serves no purpose, has prevented them from getting necessary care for.Additional information was received from a patient on 2017-jun-29.The patient stated that the device does not do any good and it was never put in as promised.The patient was redirected to follow up with their healthcare professional (hcp).No further complications were reported/are anticipated.
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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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Manufacturer Narrative
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Product id (b)(4) lot# serial# (b)(4) implanted: (b)(4) 2010 explanted: product type lead product id (b)(4) lot# serial# (b)(4) implanted: (b)(4) 2010 explanted: product type lead product id (b)(4) lot# serial# (b)(4) implanted: (b)(4) 2010 explanted: product type lead product id (b)(4) lot# serial# (b)(4) implanted: (b)(4) 2010 explanted: product type lead : due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.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 stated that the current ins and/or programming did not reach the desired pain area, but the lead could not be replaced because "the lead could never reach that far".The patient was redirected to their healthcare provider (hcp).There were no reported complications and no further complications were expected.
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