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

Model Number	FR4A-TRL-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported post-op procedural pain and swelling and they are not getting pain relief.Therapy was never achieved and the trial was removed on (b)(6) 2022.The swelling has decreased and the patient is doing fine.
Additional Manufacturer Narrative
No therapy/loss of therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, migration, inadequate fixation, and no attempts to reprogram the waa have been ruled out as potential causes.However, the patient has contraindicating conditions including morbid obesity, diabetes, and a history of swelling.The stimulator is used to treat pain.The cause of the reported issue is due to the patient being a poor candidate due to health, weight, age, or mental capacity as they are morbidly obese, have diabetes and a history of swelling (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in loss of therapy/no therapy issues.Loss of therapy/no therapy issue rates remain acceptably low; thus, capa is not required. loss of therapy/no therapy issue rates will continue to be tracked and trended.

• 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: 15973893
• Report Number: 3010676138-2022-00148
• Device Sequence Number: 15184048
• Product Code: GZF
• UDI-Device Identifier: 00818225020709
• UDI-Public: (01)00818225020709(17)240701
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/13/2022

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: 07/01/2024
• Device Model Number: FR4A-TRL-B0
• Device Lot Number: SWO220711
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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
• Patient Sex: Unknown