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

Model Number	FR8A-RCV-A0
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	02/11/2022
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 stimulator, not prepping the skin with antiseptic solution, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes of the reported issue.The questionnaire shows the surgical site was not irrigated before closure and it is unknown whether the patient had any contraindicating conditions or if antibiotics were used pre-operatively.The patient engaged in minor physical activity following the implant procedure.Additionally, the patient has low body mass and the clinician believes the bump is the knot in the lead placed to set the receiver.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 cause of the bump and pain is likely due to the patient being a poor candidate due to health, weight, age, or mental capacity (user error -clinician; patient has low body mass).
Event or Problem Description
The patient reported a bump/knot near the lower incision that is painful.The implanting clinician reported the incision is not infected (no redness, not warm to the touch and not swollen) and it is not eroding from the skin.There will be a follow up appointment in 4-6 weeks to ensure the pocket continues to heal without incident.No revision/explant is scheduled at this time.

• 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: 13720289
• Report Number: 3010676138-2022-00030
• Device Sequence Number: 6055390
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: 010081822502069317230201
• 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): 03/09/2022

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: 02/01/2023
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO210214
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/10/2022
• 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
• Patient Sex: Unknown