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

Model Number	FR4A-TRL-A0
Health Effect - Clinical Codes	Discomfort (2330); Skin Inflammation/ Irritation (4545)
Date of Event	07/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trial patient reporting discomfort/irritation leading to the trial lead being removed on (b)(6) 2021.On (b)(6) 2021, the patient was scanned for blood clots which was negative.The trial patient only obtained forty percent pain relief and decided not to move forward with a permanent implant.No further issues were reported.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile device, implanting an expired device, not using antibiotics, not prepping the skin, using inappropriate tools, patient touching the wound or engaging in strenuous activities, and multiple tunneling attempts have been ruled out as potential causes.The implanting clinician stated that the cause of the infection was unknown.However, the questionnaire shows that the implanting clinician did not irrigate the site before closure, which may have contributed to the occurrence.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 discomfort/irritation could be due to not irrigating the site before closure (user error-clinician).
Event or Problem Description
Patient is having discomfort related to the lead even when stimulation is turned off.

• 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: 12264336
• Report Number: 3010676138-2021-00163
• Device Sequence Number: 19960120
• Product Code: GZF
• UDI-Device Identifier: 00818225020716
• UDI-Public: 010081822502071617221201
• Combination Product (Y/N): Y
• 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): 08/02/2021

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: SWO201216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2021
• Initial Report FDA Received Date: 08/02/2021
• 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