MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-SPR-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The commercial team member reported a patient was going to have their neurostimulators explanted.Several attempts were made to contact the patient for additional information without success.The commercial team member noted the patient had some problems with overstimulation in the past and the transmitter settings were adjusted accordingly.Additionally, the patient was hospitalized for an unrelated abdominal infection and underwent surgeries for unrelated intestinal/gastric issues.After these issues, the patient stopped using their device.An explant procedure was performed on (b)(6) 2024.No further information was provided.
Additional Manufacturer Narrative
The loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, the incorrect questionnaire was completed.Potential causes of overstimulation are programming parameters, migration, interference from a non-curonix device, patient is a poor candidate due to health, weight, age, mental capacity, severe force applied to implant (patient fall, accidents), and off-label use.Implanting the device in an off-label location, patient contraindicating conditions, and migration have been ruled out as potential causes.The stimulator is used to treat pain.The cause of overstimulation is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, the conclusion has been selected as unable to determine the root cause.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, a capa is not required at this time.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): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer Contact: tena jimmerson ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 20152889
• Report Number: 3010676138-2024-00177
• Device Sequence Number: 11830953
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)221001(01)00818225020495(17)230801(21)2B13344-61
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 09/05/2024

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: 10/01/2022
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO201025, SWO210809
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2020
• 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 Age: 73 YR
• Patient Sex: Female