MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-B0, FR4A-TRL-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	12/15/2022
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 the leads after the expiration date, not prepping the skin with antiseptic solution, not irrigating the incision site with antibiotic solution, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes.The implanting clinician believes the irritation was caused by tegaderm, not the stimwave device.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 provided information does not evidence that the stimwave device contributed to the issue and the allergy is unrelated to the stimwave device (no fault found).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, capa is not required. surgical issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported redness, itchiness and fluid at the lead pull.Antibiotics were prescribed and the physician thinks it might be an allergy to tegaderm.The patient is improving and is being scheduled for a permanent implant procedure.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• 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: 16142798
• Report Number: 3010676138-2023-00005
• Device Sequence Number: 6669318
• Product Code: GZF
• UDI-Device Identifier: 00818225020709
• UDI-Public: (01)00818225020709(17)240401(01)00818225020716(17)240301(21)2B14806-66
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2023

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: 04/01/2024
• Device Model Number: FR4A-TRL-B0, FR4A-TRL-A0
• Device Lot Number: SWO220428, SWO220322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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