MAUDE Adverse Event Report: CURONIX LLC STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Patient Problems Purulent Discharge (1812); Failure of Implant (1924)

Event Type  Other  

Event Description

We were informed on 07 february 2024 that the patient underwent an explant procedure due to ineffective therapy.During the procedure, a curonix electrode was also explanted.In addition, pus was noted during the explant procedure.The explant occurred on (b)(6) 2024.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
• Type of Device: STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): CURONIX LLC
• MDR Report Key: 18994296
• MDR Text Key: 338943518
• Report Number: MW5153327
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1