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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Impaired Healing (2378)
Event Date 04/06/2023
Event Type  Injury  
Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the stimulator after the expiration date, not prepping the skin with antiseptic solution, using inappropriate tools, and multiple tunneling attempts have been ruled out as potential causes.Additionally, the patient does not have any contraindicating conditions.The clinical representative believes the site was not irrigated with antibiotic solution before closure.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of the reported issue is due to the site not being irrigated with antibiotic solution before closure (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 their incision was not healing and it hurt.The implanting physician removed an extra stitch, applied steri-strips and bandages, and antibiotics were prescribed.An explant procedure was performed on (b)(6) 2023, the incision was washed out with an antibiotic solution and additional antibiotics were prescribed.The patient plans to follow up with their physician.
 
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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
MDR Report Key16864674
MDR Text Key314506187
Report Number3010676138-2023-00059
Device Sequence Number1
Product Code GZF
UDI-Device Identifier00818225020464
UDI-Public(01)00818225020464(17)241001
Combination Product (y/n)N
Reporter Country CodeUS
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 05/03/2023
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 Model NumberSTQ4-RCV-A0
Device Lot NumberSWO100522
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/06/2023
Initial Date FDA Received05/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
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