MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-SPR-B0
Medical Device Problem Codes	Fracture (1260); Use of Device Problem (1670)
Health Effect - Clinical Codes	Abscess (1690); Bacterial Infection (1735)
Date of Event	05/31/2024
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, the questionnaire was completed with limited information.However, the patient has several non-curonix devices implanted which may have contributed to the reported issue.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev.6 : "safety has not been established for patients who use the freedom pns system with other active implantable or body-worn medical devices.These devices include other neurostimulation systems, insulin pumps, automated external defibrillators (aed), cochlear implants, and wearable medical sensors".The stimulator is used to treat pain.The cause of the abscess is unknown.However, the as analyzed code was selected as interference from a non-curonix device as the patient has several non-curonix devices implanted in their back as well as pelvis (user error-clinician).Additionally, an incorrect surgical technique was noted as the surgeon pulled out a pencil eraser sized power unit during the i&d procedure (user error-clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, a capa is not required at this time.Surgical issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported an abscess on their lower back.Antibiotics were prescribed and a general surgeon performed an incision and drainage (i&d) of the abscess.Cultures were obtained which revealed staph aureus positive cultures.Additionally, during the procedure, the surgeon pulled out a pencil eraser sized power unit.The patient was referred back to their implanting clinician for follow-up.During their follow-up appointment on (b)(6) 2024, x-rays were obtained which revealed the patient had non-curonix scs leads as well as another unidentifiable lead in the pelvis.As of (b)(6) 2024, the patient is under the care of infectious disease, taking oral antibiotics, and receiving wound care.The patient is not using their device and an explant procedure will be performed once the infection settles.However, a date has not yet been scheduled.

• 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: 19984474
• Report Number: 3010676138-2024-00156
• Device Sequence Number: 17942369
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)211001(01)00818225020495(17)210401(21)201263-43
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 08/14/2024

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: 10/01/2021
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO191025, SWO190423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female