|
Information was received from a patient with an implantable neurostimulator (ins) for non-malignant pain.The patient reported bein g sore since implant.They have a follow up appointment with their healthcare professional (hcp) on (b)(6) 2017 no further complications were reported/are anticipated.Additional information was received from a patient on (b)(6) 2017.The patient stated that since being implanted their legs start to get stuff and their pain returns when they do not have their patient programmer antenna over the implant.It is difficult to keep the antenna over the implant all of the time because it slips when they change positions.It was reviewed that the antenna does not need to constantly be over the implantable neurostimulator (ins).It was reviewed that it only needs to be over the ins when they want to communicate and make changes.The patient also stated that they cannot weight their recharger belt because their back is still sore.The patient also noted that their left leg is burning really bad beginning about three days ago and they are not sure why.The manufacture representative (rep) programmed the device so that the batter would last until their appointment on the (b)(6).At the appointment they would go over recharging and how to work the equipment.No further complications were reported/are anticipated.Additional information was received from a healthcare professional (hcp) on (b)(6) 2017.The hcp stated that the patient used ice and pain medication to resolve their soreness.No further complications were reported/are anticipated.Additional information received from the patient reported that they are always in pain, and that the therapy was not effective.The patient was reprogrammed by several reps but the issue has not resolved.The patient last met with a rep around the (b)(6) 2018 and they were advised to change programs every 2 weeks.The patient noted that a couple weeks ago their legs started getting worse, then later clarified that they had always been like that.The patient had been changing programs which had been working, though now only 1 program (d) was actually working.The patient's hcp was planning to do an x-ray to check if the leads were in the right place.The patient's next appointment was scheduled for sometime in (b)(6) 2018.No further complications were reported.Additional information was received from the patient.The patient reiterated that the therapy had not been effective since implant.The patient reported that they had difficulty walking, sitting, and sleeping from the pain.The patient was supposed to see a manufacturer representative (rep) on the day of the call at their doctor's appointment, but they didn't hear back from the rep.No further complications are anticipated.Additional information was received from the patient¿s attorney and from the patient on (b)(6) 2018.The caller indicated that their client¿s pain stimulator is not working properly.The patient has been trying to get through but has not had any success so patient services made an outbound call to the patient.The patient confirmed that their device is not working properly.Since they have had it, they have been tweaking, and tweaking, and tweaking, but it is not doing them any good.They are in constant pain, so the last time they called a lady told them, when they called the number, that the doctor had to call, so they couldn't call them.So the patient went to their doctor's office and told the receptionist that a month prior to the report, and the receptionist said okay but nobody called the patient.Since they have had it for two years it has never done them any good.They are always in pain.The patient stated that they were trying to tweak it to make it get better, but they have problems with both of their legs now, and their back,their legs, all of that, and their feet.They don't go to bed at night because they hurt so bad.Their doctor knew and there was a man that was doing it.They worked with several manufacture representatives (rep), a couple more other people, and the doctor told them that they apologized that it is not working, maybe it is not for them.The patient wishes that they had known that before they put this in.They are constantly in pain like this all the time.The patient states that they just have one program right now for both legs and feet.It is not doing them any good.They cannot do anything with their current settings now.The patient was always told that they need to go through the doctor¿s office to get assistance with reprogramming.They need reprogramming for some relief from the pain.The patient noted speaking with a rep in (b)(6) but they did not know their name.Patient services sent an email to local reps.No further complications were reported/are anticipated.
|
