MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMQ NEUROSTIMULATOR; PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-A0
Health Effect - Clinical Codes	Pain (1994); Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)
Date of Event	03/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2021, the implanting clinician successfully explanted the stimulator.The implanting clinician stated that the redness and tenderness might be related to an infection.The implanting clinician also noted that the patient has diabetes, which may have contributed to the infection.The implanting clinician took cultures, but results are not available.The patient was sent to the hospital for further treatment.The clinical representative mentioned the implanting clinician only used alcohol to clean the site before the implant procedure instead of chlorhexidine-based products, which are the recommended solution to be used to prepare the implant site.A stimwave representative conducted a 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 infection was not confirmed/replicated through culture, but irritation at the site was confirmed present.There is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the potential infection is due to the patient having pre-existing conditions and the site not being adequately cleaned before the implant procedure.Risk document design fmea for scs (b)(4) and hra for scs (b)(4) was reviewed and infection is a known issue with mitigation controls in place to reduce risk as far as possible therefore, no capa is required.Stimwave's global infection rate: (b)(4).The frequency is occasionally.
Event or Problem Description
On (b)(6) 2021, the patient attended a follow-up appointment with the implanting clinician for a lead pull for a suspected foot infection.

• Brand Name: STIMQ NEUROSTIMULATOR
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• MDR Report Key: 11703701
• Report Number: 3010676138-2021-00075
• Device Sequence Number: 3018803
• Product Code: GZF
• UDI-Device Identifier: 00818225020716
• UDI-Public: 010081822502071617221201
• 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
• Device Explanted 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): 04/21/2021

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: 12/01/2022
• Device Model Number: FR4A-TRL-A0
• Device Lot Number: SWO201216A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1