Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3387s-40, lot# va0p59t, implanted:(b)(6) 2015, product type: lead.Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead.Product id: 3708660, serial# (b)(4) ,implanted: (b)(6) 2015, product type: extension.Product id: 37642, serial# (b)(4), product type: programmer, patient.Product id: 3708660, serial# (b)(4), implanted:(b)(6) 2015, product type: extension.Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.(b)(4).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.
|
A manufacturing representative reported that about a month after implant, electrodes 1 and 3 had a short and the patient's tremor had returned.The patient's indication for use is parkinson's dual and movement disorders.Impedances were measured to be fine after implant.About six weeks after implant, the short had resolved and the manufacturing representative was able to program those electrodes again so the patient received efficacy.On the day of this report, the manufacturing representative was meeting with the patient and the short had returned.A revision was done to replace the extension and the implantable neurostimulator (ins) due to the short draining the battery.The initial problem started after the patient had a fall.After the surgery, impedances were checked and they looked good.The low impedances had increased by 600 ohms.The manufacturing representative planned to meet with the patient tomorrow to program the ins.Following the revision the patient had recovered without sequela.
|