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

Model Number	FR8A-TRL-A0
Health Effect - Clinical Codes	Purulent Discharge (1812); Erythema (1840); Pain (1994); Swelling/ Edema (4577)
Date of Event	10/25/2021
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 a device after the expiration date and not prepping the skin with an antiseptic solution have been ruled out as potential causes.However, the questionnaire shows the site was not irrigated before closure and it is unknown if multiple attempts or inappropriate tools were used.The patient was very active after the trial and went to the beach.The patient also stated they did not interfere with the would and it is unclear if they moved the tegaderm; however, the dressing was not in the original location where it was placed.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 pain and tenderness is due to non-compliance to the ifu by interfering with the prescribed post-op wound care (user error - patient).
Event or Problem Description
The patient reported pain and tenderness at the incision site.It appeared part of the tegaderm had pealed up, leaving the tail end of the lead exposed.The physician noted the incision site was red, swollen and had pus as well.Because it looked like the beginning of an infection, antibiotics were prescribed and an explant was performed on (b)(6) 2021.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: 12856110
• Report Number: 3010676138-2021-00233
• Device Sequence Number: 4351115
• Product Code: GZF
• UDI-Device Identifier: 00818225020792
• UDI-Public: 010081822502079217230701
• 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): 11/22/2021

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: 07/01/2023
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO210713
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/22/2021
• 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