MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR; TRANSMITTER ASSEMBLY

Model Number PDBT-915-2K, PDBT-915-2K

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

Patient Problem Pain (1994)

Event Date 10/25/2023

Event Type  Injury  

Event Description

The patient reported increased pain and requested programming.On (b)(6) 2023, the clinical representative met with the patient to complete a reprogramming session.After the reprogramming, the patient reported significant improvement in therapy and the clinical representative educated the patient on how to wear the antenna correctly.

Manufacturer Narrative

The loss of therapy/no therapy issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, not achieving paresthesia on the table, not performing x-rays immediately after the procedure to confirm placement, and inadequate fixation have been ruled out as potential causes.The questionnaire shows the patient has implanted devices/metal hardware.Additionally, the patient was not wearing the antenna in the correct position.The patient confirmed the increased pain was the return of the original pain and not as the result of new pain.However, the patient's issue was resolved after reprogramming.The stimulator is used to treat pain.The cause of the increased pain is due to programming parameters as reprogramming resolved the reported issue (user error - clinical representative).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, capa is not required. loss of therapy/no therapy issue rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: TRANSMITTER ASSEMBLY
• 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: 18179329
• MDR Text Key: 328621379
• Report Number: 3010676138-2023-00244
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020150
• UDI-Public: (01)00818225020150(01)00818225020150(21)608A108BB999
• 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: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PDBT-915-2K, PDBT-915-2K
• Device Lot Number: 00655-DT, 00655-DT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2022
• 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 Age: 75 YR
• Patient Sex: Male