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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR
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CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR Back to Search Results
Model Number STQ4-RCV-A0
Device Problem Off-Label Use (1494)
Patient Problem Pain (1994)
Event Date 05/23/2023
Event Type  Injury  
Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device after the expiration date, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes.However, the stimulator was implanted in an off-label location.The stimulator is used to treat pain.The cause of the reported issue is off-label use as the device was implanted mid-cheekbone, with the distal contact below the pupil of the eye (user error - clinician).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.
 
Event Description
The patient reported facial pain caused by the lead placement as stretching their mouth (smiling, talking, yawning, etc.) causes pain.The patient has a follow-up appointment on (b)(6) 2023 and the plan is to reposition the lead by moving it backwards slightly.
 
Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device after the expiration date, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes.However, the stimulator was implanted in an off-label location.The stimulator is used to treat pain.The cause of the reported issue is off-label use as the device was implanted mid-cheekbone, with the distal contact below the pupil of the eye (user error - clinician).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.
 
Event Description
The patient reported facial pain caused by the lead placement as stretching their mouth (smiling, talking, yawning, etc.) causes pain.The patient has a follow-up appointment on (b)(6) 2023 and the plan is to reposition the lead by moving it backwards slightly.On june 27, 2023, it was reported that the stimulator did not migrate and the transmitter assembly was reprogrammed as they did not want to risk losing any efficacy already obtained.
 
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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 Key17166008
MDR Text Key317503526
Report Number3010676138-2023-00085
Device Sequence Number1
Product Code GZF
UDI-Device Identifier00818225020402
UDI-Public(01)00818225020402(17)240101
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K171366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/27/2023
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 Expiration Date01/01/2024
Device Model NumberSTQ4-RCV-A0
Device Lot NumberSWO220118
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/23/2023
Initial Date FDA Received06/20/2023
Supplement Dates Manufacturer Received05/23/2023
Supplement Dates FDA Received06/27/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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