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

Model Number	FR8A-TRL-A0
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	02/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting an expired stimulator and not prepping the skin with antiseptic solution were ruled out as potential causes of the reported issue.Other potential causes of the reported issue are touching/picking the wound, implanting a non-sterile device, not irrigating before closure, not using antibiotics pre-operatively, using inappropriate tools and multiple tunneling attempts.The questionnaire shows the incision site was not irrigated with antibiotic solution and the patient did not take antibiotics pre-operatively.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 cause of the reported issue is potentially due to the site not being irrigated before closure (user error - clinician).
Event or Problem Description
The patient reported swelling, pain, and tenderness at the incision site.The trial lead was explanted on (b)(6) 2022 prior to the scheduled removal.Antibiotics were prescribed postoperatively however the patient did not take them.The patient is doing better and no further issues have been reported.

• 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: 13933309
• Report Number: 3010676138-2022-00037
• Device Sequence Number: 4654536
• Product Code: GZF
• UDI-Device Identifier: 00818225020792
• UDI-Public: 010081822502079217230201
• 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
• Device Explanted 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): 03/28/2022

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: 02/01/2023
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO210216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2022
• Initial Report FDA Received Date: 03/28/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown