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

Model Number	FR8A-TRL-A0
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Blister (4537); Skin Infection (4544)
Date of Event	01/16/2022
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 device and not prepping the skin with antiseptic solution have been ruled out as potential causes.However, the questionnaire shows it is unknown if the site was irrigated before closure or if antibiotics were prescribed pre-operatively, which are potential causes of the occurrence.There was no indication that the patient interfered with the dressing.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.Cause cannot be identified with the available information; thus, investigation has concluded as no fault found.
Event or Problem Description
The patient reported the skin entry site was red, raised, painful, and had blisters after the lead pull.Antibiotics were prescribed and an explant procedure was performed on (b)(6) 2022.The patient is doing better and the wound is healing after a second round of antibiotics.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: 13527889
• Report Number: 3010676138-2022-00021
• Device Sequence Number: 14731334
• Product Code: GZF
• UDI-Device Identifier: 00818225020792
• UDI-Public: 010081822502079217230901
• 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): 02/14/2022

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: FR8A-TRL-A0
• Device Lot Number: SWO210905A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2022
• Initial Report FDA Received Date: 02/14/2022
• 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