MAUDE Adverse Event Report: NEVRO CORP. SENZA OMNIA IPG KIT; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	NIPG2500
Health Effect - Clinical Codes	Failure of Implant (1924); Burning Sensation (2146); Inadequate Pain Relief (2388); Skin Inflammation/ Irritation (4545); Implant Pain (4561)
Date of Event	09/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Incident happened (b)(6) 2022, location: (b)(6) hospital.Nevro rep on site at the time of replacement of ipg, due to program me checks and re-training of new remote for ipg.(flew in from england, was late due to customs clearance on my ipg which she had carried on person) surgery was late.Pain management consultant trained on procedure by nevro corp regarding replacement ipg.On the (b)(6) 2022, i had my ipg replaced for a nevro spinal cord stimulator as my old ipg was at its 10-year shelf-life expectancy.I was informed by the consultant that my ipg site would be closed with staples previous to surgery.I had my questions regarding this as i am quite aware from my employment at the time as adverse reporting high risk of infection etc.With this method.Most surgeons implanting spinal cord stimulators advice not to close the patient due to high-risk infection plus a patient cannot charge with staples in place.I also highlighted this matter to the nevro rep when she arrived and she stated this is the surgeon¿s preference, (nevro's states ipg site closed with staples as it can cause skin burns with charging or interfere with the ipg, ifu states no metal between charge paddle and ipg during charge.) *please see patient manual nevro*.I further questioned the nevro representative regarding charging with staples in place and she informed me that it was ok to charge, but to mind as it is a fresh wound and to start my charging the next day for 10 to 15 mins and work up daily to my complete charge time of 40 to 45mins.Please note the staples were in place till the (b)(6) and full charge time of 45mins was met.On removal of the staples i was a bit concerned of persistent pain at the ipg site, i noticed especially after charging the pain got worse each time, i have difficulty in sitting for long periods, driving, exercising, walking up the stairs, lying on my back or side of the ipg which is located in my left buttocks.Wearing underwear is a challenge as it lays on the ipg site, wearing jeans or tight leggings etc.Causes a pain.The ipg feels at times that it is moving, causing a tearing sensation inside my left buttock.When charging my skin feels raw and stinging sensation.I had to give up my job due to this and it has affected my quality of life.On review with another pain management specialist it was brought to my attention that staples aren't advised not to charge with them in place.I already had some tests to see what is the problem apart from metal burns, nerve damage and irritation to the muscles in my buttocks.Ipg was removed and replaced in (b)(6) 2023, it was noticed at this stage that the ipg had slipped out of its pockets, also that the leads were extremely dirty which meant they were never wiped clean during the first replacement leading to me impeding twice, one lead is completely useless now and i cannot have an mri.This surgeon is listed by nevro as being trained and competent.There is no nevro reps available to any irish patients of nevro spinal cord stimulators in ireland, i have contacted hpra regarding regulations on no reps from nevro within ireland, that a rep is coming in from a country that is no longer in the eu, and do they have restriction to be coming into ireland to look after patients.Bsi, ema hpra are also notified regarding negligence.Nevro's response to hpra was that they are confident that the rep would never inform me to charge with staples.There is a paper trail from the nevro rep emails asking such, 3 days after my surgery.There are also a few other patients that were informed by the same rep, that charging with staples is allowed.All are seeking legal action regarding the same issue.I am currently trying to find someone to replace my leads, but due to the lack of patient care by nevro, most neurosurgeons are refusing to deal with nevro patients here in ireland, which might mean i will have to find an alternative device.Due to legal action this will not be submitted.Reference report: #mw5153686.

• Brand Name: SENZA OMNIA IPG KIT
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO CORP.
• MDR Report Key: 19087033
• Report Number: MW5153687
• Device Sequence Number: 15289779
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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): 04/06/2024

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: Lay User/Patient
• Device Model Number: NIPG2500
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White