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Model Number 97715
Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Application Program Problem (2880)
Patient Problems Pain (1994); Ambulation Difficulties (2544); Electric Shock (2554); Insufficient Information (4580)
Event Date 05/30/2021
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The patient reported that in (b)((6) 2021 they started having pain.   they wanted to know how to increase stimulation to see if they could get better relief.  patient services (ps) assisted the patient with increasing stimulation on different groups, and the patient confirmed they could feel stimulation slightly. The patient was going to see if those changes would work or not.  the patient called back the next day and inquired which parts of their body each group or program could cover.  they were redirected to their doctor to discuss that.  no device issues reported. Additional information was reported that the patient has pain in their lower back and down their left leg. Additional information received. Pt explained that the first mdt rep to program them (b)(4) told them to just charge their implant and don't worry about anything else. Pt was still experiencing pain so mdt rep, (b)(4) preprogrammed pt again. Pt is still not getting relief from their therapy and is becoming frustrated. Pt (b)(6) mentioned they spoke with mdt rep (b)(4) and was instructed to make an appointment with their hcp. Ps explained the role of the rep to pt and that they can only be seen by the rep under the care of their hcp. Pt stated they didn't understand that concept prior to today's call. Pt stated they have an upcoming appointment on (b)(6) 2021 at 10:30am with dr. (b)(6) for reprogramming. Ps sent email to mdt rep, (b)(4) to confirm. Pt also mentioned they've dealt with back pain for 25-30 plus years and is only able to walk about 25-50 yards at a time, then has to rest before walking again. Additional information received. Patient reported after installation of the neurostimulator on (b)(6) i started to walk to a park on (b)(6) about yi mile from our house. Walked 3 times in 3 days witch i could not do before the stimulator. On the 4th day 1h way back i started to feel some pain and within the next 200 yards the pain got vary bad, worse than what had made me stop walking before the stimulator. I think the increased pain was caused by a change in a pinch of nerve that goes to my left leg, never had pain in left leg before. I did have operation and rods put in lower back to fix the problems in the right leg, about 12 years ago. At my 6 month appointment with our family doctor who has his own back problem. He thought it could be new exercise, and muscle problem. For a vary long time the only way i could walk vary long was pushing a shopping cart or mowing lawn. Something to lean on. Covid 19 stopped shopping and kept me inside for a more than a year. When i was in late 20s i went to a chiropractor i liked, on my way out one day he stopped me and said i should plan on back trouble when i get old, i ask what i could do, he said just plan as i was built wrong. I had ask for neurostimulator because of my lower back pain that i had steroid shots in for about 10 years. The pain might be better now than it was when i first felt it. I did not fall or trip just walked carefully when i first felt the pain. I plan on getting all the stimulator can give. Right now i am using group c and adaptivestim. Set at standing 4-4-4-4 a higher setting works better at times shutting off and on helps at times might help. Laying right side 0. 3--0. 3--0. 3--0. 3 reclining 0. 3--0. 3--0. 3--0. 3 additional information received. Patient repeated information already reported. Patient also reported that they had group a and b programmed with group b being something they can feel in back and when they turn on it really jolts them. Since probably the middle of june pt started to have issues with their device and they have called (b)(4). Pt said their medtronic representative was (b)(4), the pt had seen them a couple times and last time they saw a medtronic representative (b)(4) and they said the same thing, don't pay attention to the manuel for they got new algorithms in 2 weeks after notifying the representative pt said they want more then got another fella in a different area and talked on a friday and then on monday they told the pt to call a doctor for they can't talk to them (pss understood pt tried to talk to a different medtronic representative). Pt said since (b)(6) they had been ready to tell the doctor to take the implant out. Pt said that group b really gets to you and the girl (medtronic representative) said try it for a week and pt had not adjusted their setting other than turning it down to group a and the pt was not getting help from their medtronic device. In the past 3 weeks maybe 2 weeks (b)(6) the pt had been receiving the message constantly saying settings not available cannot provide your desired intensity. Pt said they got some relief but right now they got the relief when they shut off the implant for a certain amount of time. Pt said to leave the stimulation on constantly it drives them nuts. Pt said they have had their pain for a lifetime almost for they had the same pain right now when they were (b)(6) years old and when they grew up the pain did go away. Pt said they don't have any pain when laying down or sitting but when they were vertical on their feet they hurt no matter how their intensity was set or if the stimulation was turned off (pt said they don't turn their stimulation off much) the pt c ant stand long enough to brush teeth and floss for 5 minutes. Pt said they got an appointment with the doctor and they are ready to say to take it out unless they want to program it. Pt then said they got no relief from their stimulator but one time they played with it and got relief. Pt said they got cycling and was looking forward to it because they were getting relief when the stimulator was off; if the stimulator was off 5 minutes they got relief (pt said the stimulator was left off longer in past and since their last clinician meeting they have only shut off the stimulator a couple times). Pt noted that they could not walk across street for the pain was pretty bad, then they shut off the stimulation and walked and had 10 minutes of good walking; pt said the clinician said they will set the therapy and they the pt will go about it and that was since (b)(6). Pt said they hurt and their back was sore about as low on back where they can get for their back hurts. Pt said they went to a chiropractor in their mid 20s. Pt said they were frustrated and they would like to relieve pain and wants the implant taken out. The patient was redirected to their healthcare provider to further address the issue. Pt said the first time meeting their clinician was on the (b)(6) and each time they see them the pt tells them to set to what they need it. Pt said they had experienced a lot and they don't know hot to interoperate.

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Manufacturer (Section D)
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key12391639
MDR Text Key268962843
Report Number3004209178-2021-13135
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/30/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/25/2021
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial