MAUDE Adverse Event Report: Curonix LLC Freedom Peripheral Nerve Stimulator

Model Number	STQ4-RCV-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed.However, there were no alleged deficiencies as therapy was working properly and the death was unrelated to the curonix device.The transmitter assemblies associated with the complaint were returned.Although the transmitter assemblies were working properly and there were no alleged deficiencies, the investigation found a damaged component as l12 was broken on both devices.The damages observed are considered cosmetic and did not effect the functionality of the device.The stimulator is used to treat pain.The cause of the patients death is unrelated to the curonix device.The provided information does not evidence that the curonix device contributed to the issue (no fault found).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issues rates remain acceptably low; thus, a capa is not required.Other adverse events issues rates will continue to be tracked and trended.Refer to capa-2024-0020 for additional investigation details for the damaged component l12.
Event or Problem Description
Curonix support was notified the patient had passed on (b)(6) 2026 from non-device related factors.There were no alleged deficiencies, therapy was working properly, and the family would be returning the transmitter assemblies.

• Brand Name: Freedom Peripheral Nerve Stimulator
• Common Device Name: Peripheral Nerve Stimulator
• Manufacturer (Section D): Curonix LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): Curonix LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064 ; +1(800)965-5134
• MDR Report Key: 50718039
• Report Number: 3010676138-2026-00188
• Device Sequence Number: 21492858
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• UDI-Public: (01)00850051034406(17)260601
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/10/2026

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: 06/01/2026
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO240617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• 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: Transmitter Assembly SN: (b)(6), LN: 01165-DT.; Transmitter Assembly SN: (b)(6), LN: 01165-DT.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 88 YR
• Patient Sex: Female