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

Model Number	FR8A-SPR-B0
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	11/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
For the report of loss of therapy: the perm - loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device in an off-label location and no attempts to reprogram the waa were ruled out as potential causes of the reported issue.Other potential causes of loss of therapy/no therapy are stimulator placement too close to the nerve, improper stimulation parameters, stimulator damage during/before implant procedure, patient co-morbidities, and patient expectations.Migration was ruled out via x-ray.For the report of shock: the clinical representative reported the patient stated experiencing an occasional shocking sensation due to the programmed amplitude being set too high.The clinical representative reduced the amplitude and the patient is receiving minimal relief, but is no longer experiencing the shocking sensation.Potential causes of shock/unintended stimulation include stimulation parameter settings, stimulator placement too close to the nerve, mri induced stimulation, implanting the stimulator too close to the nerve, stimulator electrical failure and interference from other electro magnetic sources.The waas were not returned as they appear to be functioning as expected and the rep will continue with standard reprogramming to establish therapy.The stimulator is used to treat pain.The cause of loss of therapy is unknown.However, the cause of the overstimulation/shocking sensation is likely due to incorrectly programmed waa stimulation parameters (user error - clinical representative).
Event or Problem Description
On (b)(6) 2021, the patient reported a loss of therapy.The stimwave clinical representative attempted reprogramming the waa to re-establish pain relief.When the clinical representative increased the amplitude of the programming parameters, the patient reported feeling a shocking sensation.The shocking sensation experienced by the patient was reported by the clinical representative to stimwave quality on (b)(6) 2022.The patient is currently receiving minimal relief.

• 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: 13514298
• Report Number: 3010676138-2022-00019
• Device Sequence Number: 4207700
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: 010081822502064817230501
• 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): 02/10/2022

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: 05/01/2023
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO210530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 02/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: WAA (PDBT-915-2K), SN: (B)(4); WAA (PDBT-915-2K), SN: (B)(4)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown