MAUDE Adverse Event Report: CURONIX FORMALLY STIMWAVE/CURONIX LLC SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Health Effect - Clinical Codes	Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388); Numbness (2415); Ambulation or Postural Difficulties (2544)
Date of Event	08/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I had a curonix spinal cord stimulator implanted on (b)(6) 2023 and to date (b)(6) 2023 they have yet to properly program the device to help with pain nor have they provided me the proper wearable for their device.The current settings on the device help with the shock like sensations but cause numbness in legs and feet making it nearly impossible to walk or stand.My rep (b)(6) from curonix has never programmed a spinal cord stimulator.The out of area rep they sent to help (b)(6) on surgery day wasn't qualified to be in the operating room due to lack of state required medical accreditation.I had to sign a waiver allowing her to be in the room as a guest.This meant she wasn't there in the capacity to give (b)(6) medical advice.After attempting to program the device i could see that (b)(6) lacked medical experience to program it for me and i asked for another rep.He sent a woman that was part of the sales side of curonix to help me.She has tried to get help from curonix and no one will return her calls.I reached out to medicare to file a complaint but they aren't able to help since curonix hasn't billed for the device.I believe they are not filing the claim with medicare because they are aware that they have not provided a proper wearable and program for me.I also have my surgeon reaching out to curonix.

• Brand Name: SPINAL CORD STIMULATOR
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): CURONIX FORMALLY STIMWAVE/CURONIX LLC
• MDR Report Key: 18075440
• Report Number: MW5147805
• Device Sequence Number: 14458081
• Product Code: GZB
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/20/2023

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
• Operator of Device: Other
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALLER-FLO 2 SPRAYS PER DAY AS NEEDED.; ANASTROZOLE .5MG 3 TIMES PER MONTH.; DEPO TESTOSTERONE 1ML (200 MG PER ML) 3 TIMES PER MONTH. ; DHEA 100MG 1 PER DAY. ; DIAZEPAM 5 MG AS NEEDED.; FARXIGA 10 MG 1 PER DAY.; GEMFIBROZIL 600 MG 2 PER DAY.; GLYBURIDE/METFORMIN 5/500 MG 4 PER DAY.; IBUPROFEN 800 MG AS NEEDED.; LISINOPRIL 10 MG 1 PER DAY.; LOW DOSE ASPIRIN 1 PER DAY.; OMEGA FISH OIL 800EPA, 600DHA 2 PER DAY.; PREGABALIN 150 MG 2 PER DAY; TADALAFIL 20 MG AS NEEDED; TOUJEO MAX 300U/ML PEN 80 UNITS PER DAY.; VERAPAMIL 360 MG 1 PER DAY.; VITAMIN D3 125 MSG 1 PER DAY.
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White