Concomitant medical products: product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2020, product type: extension.Product id: 3389s-40, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Product id: 3389s-40, serial#: (b)(4), implanted: (b)(6) 2020, product type: lead.Product id: 3708660, serial#: (b)(4), implanted: (b)(6) 2020, product type: extension.The main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: 09-mar-2024, udi#: (b)(4).Product id: 3389s-40, serial/lot #: (b)(4), ubd: 09-mar-2024.Product id: 3389s-40, serial/lot #: (b)(4), ubd: 09-mar-2024.Product id: 3708660, serial/lot #: (b)(4), ubd: 09-mar-2024, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
|
It was reported that patient says for about a week she¿s been noticing buzzing in her head and tingling face/jaw periodically.Started out 1 time per day and now is happening 3-4 times per day.There have been no reported falls and no changes to therapy settings.Troubleshooting includes patient is going to try lowering her settings to see if it resolves.Also, will try and shut therapy off for a day and see if it occurs with stimulation off.The issue was not resolved.Additional information was received.It was reported that the buzzing sensation occurs when the lead/extension connection is pressed on the head.All impedances were in normal range.The battery site was also tight for the patient.The patient was going to see the neurosurgeon to have the tension on the implant fixed.No surgery date scheduled yet.There doesn't appear to be an issue with hardware, just that there was too much tension and some coiled extension wire needs to be given so it's not so tightly implanted.The issue has not yet resolved pending the surgery.Additional information was received.It was reported that surgery hasn't been scheduled yet.Everything is tunneled to the patient's right side and implantable neurostimulator in right side of chest.Everything is pulling and tight.The battery wasn't left with enough slack and has scarred down and was tight for the patient.
|