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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CURONIX LLC FREEDOM NEUROSTIMULATOR
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CURONIX LLC FREEDOM NEUROSTIMULATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994)
Event Date 11/05/2021
Event Type  Injury  
Event Description
The patient reported intense pain and inflammation.A patch was used at the lower lumbar area.No additional information provided.
 
Manufacturer Narrative
The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of pain are incorrect programming parameters, migration, patient contraindicating conditions, interference with a non-stimwave device, overstimulation, and nerve/tissue damage.The stimulator is used to treat pain. the cause of the reported issue is unknown. therefore, conclusion has been selected as no problem/fault found.Capa-2023-0001 was initiated to investigate and remediate the noncompliance to company reporting procedures.
 
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Brand Name
FREEDOM NEUROSTIMULATOR
Type of Device
FREEDOM NEUROSTIMULATOR
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 Key17353752
MDR Text Key319389115
Report Number3010676138-2023-00119
Device Sequence Number1
Product Code GZF
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 07/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received11/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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