MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINAL CORD NERVE STIMULATOR

Model Number	FR8A-TRL-B0
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 the patient was implanted with a trial spinal cord nerve stimulator in the epidural space.On (b)(6) 2022 the patient reported swelling in their left foot.Antibiotics were prescribed although an infection was not confirmed.An explant procedure was performed on (b)(6) 2022, and no further issues have been reported.
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, implanting the stimulator too close to the targeted nerve, and migration have been ruled out as potential causes of the reported issue.The stimulator is used to treat pain.The cause of swelling is unknown.Therefore, conclusion has been selected as no problem/fault found.Note: complaint determined to be reportable upon notification of medical intervention (antibiotics prescribed).

• Brand Name: FREEDOM NEUROSTIMULATOR
• Common Device Name: SPINAL CORD 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: 14501500
• Report Number: 3010676138-2022-00069
• Device Sequence Number: 5123643
• Product Code: GZB
• UDI-Device Identifier: 00818225020662
• UDI-Public: 010081822502066217240101
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: 01/01/2024
• Device Model Number: FR8A-TRL-B0
• Device Lot Number: SWO220118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 05/25/2022
• 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