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

Model Number	PDBT-915-2K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported periodic shocking sensation during use of the transmitter.They received adequate therapy with no shocking with their other trial transmitter on the same programming parameters.The leads were pulled on (b)(6) 2023 at the end of their trial period and no further issues have been reported.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, changing the waa parameters, the patient having a non-curonix device implanted, and the patient feeling unintended stimulation/new pain in a new area that is not targeted for therapy were ruled out as potential causes of the reported issue.Additionally, the device did not migrate, the patient did not experience loss of therapy, the device was not implanted too close to the nerve, and the waa parameter settings were not too high.Rma-8331 was received and investigated by engineering.The investigation of the device confirmed specifications were met and no non-conformances were found.The stimulator is used to treat pain.The cause of the shocking sensation is unknown.Therefore, conclusion has been selected as no problem/fault found.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, capa is not required. unintended stimulation/new pain issue rates will continue to be tracked and trended.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, changing the waa parameters, the patient having a non-curonix device implanted, and the patient feeling unintended stimulation/new pain in a new area that is not targeted for therapy were ruled out as potential causes of the reported issue.Additionally, the device did not migrate, the patient did not experience loss of therapy, the device was not implanted too close to the nerve, and the waa parameter settings were not too high.Rma-8331 was received and investigated by engineering.The investigation of the device confirmed specifications were met and no non-conformances were found.The stimulator is used to treat pain.Although the returned waa met specifications, the cause of the reported issue is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, capa is not required. unintended stimulation/new pain issue rates will continue to be tracked and trended.Updated per fda capa-2023-0013 correction 2.
Event or Problem Description
The patient reported periodic shocking sensation during use of the transmitter.They received adequate therapy with no shocking with their other trial transmitter on the same programming parameters.The leads were pulled on (b)(6) 2023 at the end of their trial period and no further issues have been reported.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: WEARABLE ANTENNA 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: 16762862
• Report Number: 3010676138-2023-00050
• Device Sequence Number: 14219002
• Product Code: GZF
• UDI-Device Identifier: 00818225020150
• UDI-Public: (01)00818225020150
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2024

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 Model Number: PDBT-915-2K
• Device Lot Number: 00715-LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: SN: (B)(6), LN: SWO220726.; SN: (B)(6), LN: SWO220726.; SN: (B)(6), LN: SWO220920.; SN: (B)(6), LN: SWO220920.
• Patient Sex: Unknown