MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINAL CORD NERVE STIMULATOR

Model Number	FR8A-SPR-B0
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The implanting clinician stated the cause of the inflammation/swelling was unknown.The patient is wearing the stimulator, and no further issues have been reported.The implanting clinician decided a revision/explant was not needed at this time.The 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 implant, and the procedure was completed following the product instructions for use.Per review of sterilization and packaging records for the respective product lot, 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 skin irritation was confirmed/replicated.There is no evidence that the product did not meet specification and the stimulator is used for treatment of pain.The cause of the skin irritation is unknown/no problem found.Design fmea 06-0537 and hra 06-0524 was reviewed and skin irritation is a known issue with mitigation controls in place to reduce risk as far as possible therefore, no capa is required.Stimwave's global skin irritation rate: 0.42% the frequency is occasionally and the impact is important.
Event or Problem Description
Patient stated that their incisions were swollen and extremely sore, which prevented them from being able to properly use the system.On (b)(6) 2021, the patient met with the implanting clinician, who examined the incisions and found no signs of infection.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Common Device Name: SPINAL CORD NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 11642489
• Report Number: 3010676138-2021-00064
• Device Sequence Number: 3100049
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: 010081822502064817220201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/01/2022
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO200206
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other