WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.
Worldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC, MN, OH, NC, AK, NY, IL, CA, NJ, KY, IA, MO, UT, FL, IN, LA, AL, MS, MD, WI, GA, VA, TX, AZ, KS, OR, CO, CT, ID, AR, OK, MA, MI, ND, NE, SD, WV, NV, HI, NH, DC, MT, ME, VT, WY, DE, NM. OUS (foreign) countries of: Canada, Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, Portugal, Japan, Australia, New Zealand, Singapore, Argentina, Brazil, Colombia, Puerto Rico
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2617-2024