MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-SPR-B0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Pain (1994)

Event Date 10/10/2023

Event Type  Injury  

Event Description

The patient reported pain and an opening of the skin and exposure of the lead after stretching.The clinician cleaned out the wound and restitched it.The patient was not given antibiotics, the wound has healed, and the patient is getting adequate therapy.

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the stimulator at an off-label location, not performing x-rays immediately after the procedure to confirm the device placement, implanting a damaged stimulator, patient undergoing an mri procedure, implanting the stimulator after the expiration date, not prepping the skin with antiseptic solution, multiple tunneling attempts, using incorrect tools, inadequate fixation, and the patient not attending the post-op visit have been ruled out as potential causes.However, the questionnaire shows the patient extended/stretched.The patient was stretching, felt an unfamiliar pain, and the site opened up.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix 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 erosion is due to excessive twisting or stretching as the patient was stretching when the site opened up (user error - patient).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, capa is not required. surgical issue rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: 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 ; 8009655134
• MDR Report Key: 18096543
• MDR Text Key: 327676447
• Report Number: 3010676138-2023-00231
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)240701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2023

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
• Device Operator: Lay User/Patient
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO220726
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR