MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR; TRANSMITTER 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	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The transmitter assembly was received at curonix headquarters for investigation on october 17, 2023.The investigation of the device was unable to replicate the alleged issue, and no nonconformances were found.The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the waa providing therapy when unintended stimulation occurred, the patient having another non-curonix device implanted, changing the waa parameters intentionally or unintentionally, and the patient experiencing unintended stimulation in a new area that is not targeted for therapy have been ruled out as potential causes.The stimulator is used to treat pain.The cause of the unintended stimulation 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.
Event or Problem Description
The patient reported feeling a jolting sensation from the transmitter but not the antenna.The patient is using their other transmitter assembly (set at the same parameters) with no complaints.No additional adverse events or complications have been reported and the patient continues to have 80% relief.Additionally, the patient was provided a replacement transmitter assembly.
Event or Problem Description
The patient reported feeling a jolting sensation from the transmitter but not the antenna.The patient is using their other transmitter assembly (set at the same parameters) with no complaints.No additional adverse events or complications have been reported and the patient continues to have 80% relief.Additionally, the patient was provided a replacement transmitter assembly.
Additional Manufacturer Narrative
The transmitter assembly was received at curonix headquarters for investigation on october 17, 2023.The investigation of the device was unable to replicate the alleged issue, and no nonconformances were found.The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the waa providing therapy when unintended stimulation occurred, the patient having another non-curonix device implanted, changing the waa parameters intentionally or unintentionally, and the patient experiencing unintended stimulation in a new area that is not targeted for therapy have been ruled out as potential causes.The stimulator is used to treat pain.The cause of the unintended stimulation 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.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: 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: 18057882
• Report Number: 3010676138-2023-00225
• Device Sequence Number: 5954704
• Product Code: GZF
• UDI-Device Identifier: 00818225020150
• UDI-Public: (01)00818225020150
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/26/2024

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
• Device Model Number: PDBT-915-2K
• Device Lot Number: 00794-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/23/2023
• 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:SWO230116, PN:STQ4-RCV-A0; SN: (B)(6), LN:SWO230116, PN:STQ4-RCV-A0
• Patient Age: 84 YR
• Patient Sex: Female