ACTIVA 37601

[185113192] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10

[185113193] It was reported that the patient had experienced shocking at the implantable neurostimulator (ins) and a replacement was performed, then the patient moved to another state and shocking was still experienced as occurring "with rigorous exercise" and pain was being experienced now at the ins site. No diagnostics/troubleshooting had yet been performed. It was stated a referral would be made from the neurologist to a neurosurgeon. It was unknown if surgical intervention would be planned and the issue was not resolved at the time of reporting. Additional information was received from a manufacturer representative (rep) on 2020-mar-19. It was clarified that the shocking and replacement was the same event that was previously reported. It is unknown if the issue has been resolved and if the neurosurgeon or the neurologist has seen the patient in their office and decided on treatment. The neurosurgeon has not indicated the patient is on the schedule. Additional information was received from a consumer via a manufacturer representative (rep) on 2020-mar-24. It was reported the shocking sensation was getting worse, reiterating that the shocking sensation has continued even after implantable neurostimulator (ins) and bilateral extension replacement in october. The patient feels shocking all the time with every step they take. The patient feels it at the header block and then feels it travel up into their brain. They could not confirm if the patient feels shocking unilaterally or bilaterally but thought it was on their left side. Previously the patient mentioned feeling shocking while doing rigorous activities but then it would go away and be fine. The rep realized during the call that the patient programmer (pp) is set to simple mode, so they can't adjust stimulation at all and can only turn it off or on. The patient does not want to turn their deep brain stimulation (dbs) off as they are not on any parkinson's disease medication because they are allergic to all the ones they have tried in the past. The patient asked if they should go to the emergency room (er) for the shocking. A short circuit on 8-9 pair was noted when the patient was seen in (b)(6) with a healthcare provider (hcp). They have not been seen by the hcp or rep since. They did not have exact impedance values but provided the programming below: 3. 3v on left, 60 pw, 150 rate, 1- 2+ 3. 5v on right, 60 pw, 150 rate, c+ 9- the rep spoke to another rep who covered the replacement and they could not remember for sure if lead-only impedances were checked at the time of replacement in (b)(6). They assumed that if the head incision was opened in order to replace the extensions, they likely would have checked lead-only impedances. However, if impedances were checked, they did not have any numerical values to provide. The patient has an appointment with a neurosurgeon on friday, (b)(6) 2020. Troubleshooting involved: suggested checking electrode and therapy impedances, palpating the system to attempt to recreate shocking, imaging of system and reprogramming to avoid using 8 and 9 contacts altogether and/or bipolar programming on right side along with considering giving patient advanced adjust mode on the pp, reviewing potential short circuit is worsening causing increased shocking sensation, potential that issue is with the lead as that has not been replaced and possibility of a fluid short, reviewing it is up to the patient to go to the er if they feel it is necessary but it is unlikely anything can be done immediately in terms of the system except turning it off and patient can do that at home if necessary, suggested if shocking seems to subside in certain positions, patient can try to spend majority of time in those positions in order to receive therapy and minimize shocking until further action can be taken. The rep called back as the patient wanted to know if the shocking would be harmful for them if they decided not to turn off stimulation, such as causing a stroke, or burn them. The shocking is bad and persistent in chest and also affecting the lead/extension. They also reported the ins does seem to be moving in pocket. It was indicated that with covid, it is difficult to meet with the patient in a low risk environment. The device off does not cause shocking. When the device is turned on, the patient feels tingling in their face. This has been going on for about 8 days. The rep called back again reporting the patient has pain in the pocket with palpation. There is slight swelling at the pocket site. The patient is on antibiotics for a urinary tract infection (uti). Battery check on (b)(6) was 2. 97 volts and 2. 96 volts today, thus, the drain on the battery is not fast like a short circuit. They reprogrammed the patient with 10+ and 9-, also 11+ and 10-, but the patient is still having rigidity in hands and legs with tremors. The patient has symptom relief with c and 9, but the patient has stimulation at pocket. They gave the patient the ability to adjust stimulation. The patient is at 2 volts now rather than 3. 5 before. They were reminded that as the patient lowers stimulation level, symptoms may return, thus, it is up to the patient to determine a compromised setting for relief of more pocket sensation. Technical services also suggested trying c and 8-, however, it is not likely to help since c and 9 is already giving pocket stimulation. Possible revision if patient still can't tolerate pocket stimulation was discussed. The programmed parameters are: left 3. 3 am 60pw 150hz 2520 ohms(therapy impedance) 1. 3 ma right 3. 5 volts 60pw 150hz 953 ohms(therapy impedance) 3. 7 ma.
Patient Sequence No: 1, Text Type: D, B5