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

Model Number	FR8A-RCV-A0
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)
Date of Event	12/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient disclosed that the physician noticed that the patient had an infection, and antibiotics were prescribed.The implanting clinician also noted that the patient had been picking the wound, which may have caused the infection.The patient was referred to see a pain physician who recommended that the system be removed.The clinical representative also pointed out that the stimulator's location was off-labeled.Based on this information, the infection was confirmed/replicated.There is no evidence that the product did not meet specifications, and the stimulator is used to treat pain.The cause of the infection is due to patient picking on the wound.The dhr was not reviewed because it was not available at the time the investigation was completed.The coc was reviewed and attached to the investigation.
Event or Problem Description
On (b)(6) 2021, the clinical representative was made aware that the patient had an infection and that an explant procedure was performed on december 18, 2020.

• 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: 11376685
• Report Number: 3010676138-2021-00018
• Device Sequence Number: 4038195
• Product Code: GZF
• UDI-Device Identifier: 00859619004875
• UDI-Public: 010085961900487517191001
• 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: 2018
• Device Explanted Year: 2020
• 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): 01/25/2021

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: 10/01/2019
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO171024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 02/24/2021
• 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: Required Intervention