MAUDE Adverse Event Report: STIMWAVE/CURONIX LLC STIMWAVE STQ4; STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

Model Number	STQ4-SPR-B0
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Saw on the news that stimwave has filed for bankruptcy in 2022 and the ceo was arrested for various types of fraud, i.E.Insurance etc.All stimwave devices based on my own research has shown that my particular device is on the fda recall list.The device never really worked to relieve my pain.I reached out to the company that has taken over for stimwave on 12/26/2013 and they have my file and they are working on having someone contact me with further guidance regarding this matter.Reference report: #mw5149658.

• Brand Name: STIMWAVE STQ4
• Common Device Name: STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): STIMWAVE/CURONIX LLC
• MDR Report Key: 18418260
• Report Number: MW5149659
• Device Sequence Number: 19704804
• Product Code: GZF
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 12/26/2023

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?: Yes
• Device Model Number: STQ4-SPR-B0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COMBIVENT.; DEXILANT.; DULERA. ; EFFEXOR.; FAMOTIDINE.; FINASTERIDE.; LATANOPROST.; LINZESS.; PREGABALIN.; PROPRANOLOL.; RESPIMAT.; STIMWAVE.; TRAZODONE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White