The implanting clinician examined the patient on (b)(6) 2020, identified potential infection, and prescribed antibiotics to the patient (type, dosage, duration unknown).The implanting clinician explanted the device on (b)(6) 2020, to prevent the infection from spreading.The implanting clinician stated to the stimwave clinical representative that the patient is prone to infections due to the patient being thin and not having adequate fatty tissue to act as a barrier between the coil and the skin.The explant procedure was conducted successfully without complication.The stimwave clinical representative confirmed that the implant procedure was performed in a sterile environment with sterile field handling protocols, sterile barriers of all products used were intact before the implant, and the procedure was completed following the product instructions for use.A review of sterilization and packaging records for the respective product lot swo200209 was performed: stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.Based on this information, the infection was confirmed/replicated.There is no evidence that the product did not meet specifications.The stimulator is used for the treatment of pain.The cause of the infection is unknown/no problem found.
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