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

Model Number	FR8A-SPR-B0
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Skin Inflammation/ Irritation (4545)
Date of Event	05/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient is currently doing well and is keeping the site clean to help with the healing of the infection.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile device, patient picking on the wound, not using antibiotics, not prepping the skin, using inappropriate tools, 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 the incision site was not irrigated with antibiotics prior to closure by the implanting clinician, which is not in compliance with the ifu.The stimulator is used to treat pain.The cause of infection is due to lack of irrigation with antibiotics prior to closure and clinician user error.
Event or Problem Description
Patient is suffering from an infection which is being treated with antibiotics.The implanting clinician stated revision/explant not needed, and no further issues have been reported.

• 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
• MDR Report Key: 11943976
• Report Number: 3010676138-2021-00113
• Device Sequence Number: 4243335
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: 010081822502064817230101
• 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: 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): 06/05/2021

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: No Information
• Device Expiration Date: 01/01/2023
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO210125
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 06/05/2021
• 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