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

Model Number	FR4A-TRL-A0
Health Effect - Clinical Codes	Blister (4537); Skin Inflammation/ Irritation (4545)
Date of Event	01/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported a skin reaction and the trial lead was removed on (b)(6) 2022.The patient's skin was burning and developed extensive blisters.The patient is doing much better and almost completely healed.
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed.A potential cause of skin irritation is placing the waa directly on the skin, but the clinician stated tegaderm/stayfix was between the waa antenna and the patient's skin.The implanting clinician believes the irritation was caused by the stayfix and/or the tegaderm, not the stimwave device.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.The stimulator is used to treat pain.The provided information does not evidence that the stimwave device contributed to the issue.Therefore, conclusion has been selected as no problem/fault found.
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed.A potential cause of skin irritation is placing the waa directly on the skin, but the clinician stated tegaderm/stayfix was between the waa antenna and the patient's skin.The implanting clinician believes the irritation was caused by the stayfix and/or the tegaderm, not the stimwave device.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.The stimulator is used to treat pain.The provided information does not evidence that the stimwave device contributed to the issue.Therefore, conclusion has been selected as no problem/fault found.
Event or Problem Description
The patient reported a skin reaction and the trial lead was removed on (b)(6) 2022.The patient's skin was burning and developed extensive blisters.The patient is doing much better and almost completely healed.

• 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
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 13565460
• Report Number: 3010676138-2022-00025
• Device Sequence Number: 14915042
• Product Code: GZF
• UDI-Device Identifier: 00818225020716
• UDI-Public: 010081822502071617230901
• 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: 2022
• 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): 02/20/2022

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: 09/01/2023
• Device Model Number: FR4A-TRL-A0
• Device Lot Number: SWO210910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2022
• Initial Report FDA Received Date: 02/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown