MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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Model Number 97714 |
Device Problems
Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Use of Device Problem (1670); Low Battery (2584); Delayed Charge Time (2586); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Device Operates Differently Than Expected (2913)
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Patient Problems
Muscle Spasm(s) (1966); Pain (1994); Respiratory Distress (2045); Therapeutic Effects, Unexpected (2099); Tingling (2171); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Dyskinesia (2363); Ambulation Difficulties (2544); Electric Shock (2554)
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Event Date 08/25/2017 |
Event Type
malfunction
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Event Description
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Information was received from a consumer via a manufacturing representative (rep) regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient had a premature battery depletion.It was reported that they had an increased charging duration and an increase in pain symptoms and a decrease in typical relief provided by stimulator.The patient reported no falls or external events that led up to their current issue.It was reported that no troubleshooting has been performed at this time.The rep stated that they were notified of the event over the weekend and they reached out to the office today for a time/day to be able to meet with the patient in the office for troubleshooting.They were still waiting for a response at this time.It was reported that the issue had not been resolved at the time of the report.No surgical intervention occurred and it is unknown if surgical intervention is planned, but the rep was going to follow-up with more information.No further complications were reported/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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Event Description
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Additional information received from the manufacturing representative (rep) indicated that they met with the patient for troubleshooting on (b)(6) 2017.The rep reprogrammed the patient¿s device to optimize therapy while minimizing energy output.The patient was re-educated on recharging practices, and ensuring all of the coupling boxes are filled in.Surgical intervention is not scheduled or planned at this time.The cause of the patient¿s issues was not determined.The rep is waiting to hear back from the patient regarding their new programming to see if their issues were resolved.No further complications were reported or 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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Event Description
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Information was received from a consumer regarding an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient got the implant for back and hip issues, which had included surgery on both sides of their hip and back.The patient stated that their hips have popped out, and not the bone, but everything else.The patient stated that their battery has depleted thrice and they had a return of symptoms including back and hip pain.The patient stated that their back would "suddenly go crazy".The patient stated that it takes them 24 hours to figure out the reasons for their back hurting and it is the dead battery.The patient then charges the device.The patient stated that most recently when the device dies it took longer to charge than in the past (4.5 hrs the first day, 6.5 hrs the next then 4.5 hrs to charge the last 25%) and isn't holding a charge the same way.The patient stated it is harder to sit still for that length of time due to pain in their back and issues with the back/hip.The patient stated that in the past they would charge every week or every other week.The patient stated that they can get good coupling after reposition the antenna.The patient stated that the manufacturer's representative (rep) suggested adhesive discs, but hasn't gotten any.The patient got new programming options and was advised that with the high density settings the patient would need to charge more often.The patient stated that program b does their right hip and that is the side that is worse with their condition.The patient stated that since implant it has never been good for their left side.The patient also noted that recently their symptoms have included not being able to get up/down, get out of car, couldn't lay on table at pt, lift leg/bend, can hardly move, and spasms/can't breathe.The patient stated that they are in physical therapy.No further complications were reported or 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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Event Description
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Additional information was received from the manufacturing representative while they were with the patient, reporting that the patient was having to recharge too often.It was reported that the patient previously could charge every few weeks or even every three weeks and the device would charge in two to three hours, but they stated that in the last few weeks they were having to charge for longer.They indicated that they would monitor the coupling and readjust the antenna if the coupling dropped to even six bars.It was also indicated that the patient would notice that the device was dead due to their return of back pain.It was reported that on friday night it took them 4.5 hours to charge to 75 percent full using their recharge belt.They stated that they then had to charge again on saturday, non-stop for 6.5 hours before their ins was charged.It was indicated that the patient was recently reprogrammed however, it was indicated that the patient¿s rep reprogrammed them with high density (hd) programming (group a) on friday, (b)(6), which was after their recharging issues started to occur.It was reported that the recharging issues began the last week in (b)(6) ((b)(6) 2017).Prior to that, the patient had been using group b (which was added in (b)(6) for better coverage for their right hip/right lower back), and sometimes they accidently switched to group c.It was also reported that prior to the patient getting group a, they were in bad shape for three days and couldn't get out of bed, because of their back pain and they started to have muscle spasms from one side of their body to the other, which they have never had before.It was stated that by midday saturday, they could tell that they could move better and were able to get out of bed and therefore, they didn't want to switch off group a.The rep checked therapy impedances and the patient settings and recharge interval calculations and the results are the following: group a (hd given last friday) 3= 4- 7= 90 pw, 1000 rate, 5.1v, 455 ohms, 24 hours per day estimate= 2.32 days the patient also mentioned that they had been running the group at 3.2v on friday, but suddenly wasn't feeling anything so they turned it to 3.9v and back down to 3.7v last night.The rep believed the patient was referring to group b, but then the patient clarified that they had been using group a since last friday and turned that up to 5.9v and then turned it back down to where it was today.The following are group b¿s therapy impedances and patient settings and recharge interval calculations: group b 2+ 3- 4+ 480 pw, 60 rate, 5.4v, 482 ohms, 24 hours per day estimate= 27.89 days technical services also heard the patient mention that they were ¿zapped¿ when the rep checked their impedances on this group.The patient¿s recharge statistics were analyzed and documented on an attachment.Technical services reviewed that the ins appeared to be taking a charge like it was supposed to when given an extended period of charging time with good coupling.The patient mentioned that the sessions from (b)(6) 2017 was the first time they used the adhesive discs without their recharge belt and they stated that it was hard to keep the antenna in place as it kept moving off the device so they kept having to readjust it.It was reviewed that the ins appeared to be accepting a charge like it was supposed to and the difference between the recharge interval calculations for group a to group b were also reviewed.It was suggested that the patient go back to using their belt as that seemed to work well for them.It was also suggested that the patient keep a diary of charging habits and to be seen again in a week or two to compare their dairy to their recharge statistics.The charging efficacy and duration if the antenna loses coupling or if coupling decreases during charging were reviewed.No further complications were reported/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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Event Description
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Additional information received from the manufacturing representative (rep) indicated that the patient¿s increased pain and muscle spasms were due to a lack of stimulation from the battery depletion.In addition, the patient had inadvertently switched to a program that previously wasn t helping them, instead of having it on program b which is intended to cover their pain and spasms.It was noted that the patient was switched to high density settings on (b)(6)2017 when they met with the rep.The patient was not feeling stimulation due to the high-density settings, and increased to perception.When the rep met with the patient on (b)(6)2017, they tested impedances on program b, which is when the patient felt the tingling turn on at the strength they usually have it at.The ¿zap¿ was the from the patient feeling the stimulation come on quickly and then go away; it was not a shock.The rep stated that the patient¿s muscle spasms resolved after they switched to using an appropriate program.They noted that the recharging issue is still being observed, and that the patient was to keep a diary of recharging sessions over the next couple of weeks.No further complications were reported.
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