MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-SPR-B0, STQ4-RCV-A0
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the waa providing therapy when the new pain occurred, the patient experiencing heat sensation/shock, and changing the waa parameters intentionally or unintentionally have been ruled out as potential causes.Potential causes of pain are patient contraindicating conditions, improper placement during surgery, incorrect programming parameters, change in posture or proximity of electrode to target nerve resulting in stimulation of nerves outside the target nerve, migration, and interference from a non-curonix device.Potential causes of migration are inadequate fixation, severe force applied to implant , excessive twisting or stretching, off-label use, patient contraindicating conditions, and the patient going through an mri.Migration was confirmed and the patient did not want a revision procedure and is not wearing the device.The stimulator is used to treat pain.The cause of the new pain is due to migration.However, the cause of the migration 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 migration and new pain in their left hip.The patient has not worn the device for over a year.The patient will follow up with their physician.
Event or Problem Description
The patient reported migration and new pain in their left hip.The patient has not worn the device for over a year.The patient will follow up with their physician.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the waa providing therapy when the new pain occurred, the patient experiencing heat sensation/shock, and changing the waa parameters intentionally or unintentionally have been ruled out as potential causes.Potential causes of pain are patient contraindicating conditions, improper placement during surgery, incorrect programming parameters, change in posture or proximity of electrode to target nerve resulting in stimulation of nerves outside the target nerve, migration, and interference from a non-curonix device.Potential causes of migration are inadequate fixation, severe force applied to implant , excessive twisting or stretching, off-label use, patient contraindicating conditions, and the patient going through an mri.Migration was confirmed and the patient did not want a revision procedure and is not wearing the device.The stimulator is used to treat pain.The cause of the new pain is due to migration.However, the cause of the migration is unknown.The investigation findings do not lead to a clear conclusion about the cause of migration.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: 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: 17953917
• Report Number: 3010676138-2023-00215
• Device Sequence Number: 7670026
• Product Code: GZF
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)210701(01)00818225020464(17)211001(21)211054-115
• 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: 2019
• 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): 04/29/2024

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: 07/01/2021
• Device Model Number: FR8A-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO190701, SWO191024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2019
• 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
• Patient Sex: Female