MAUDE Adverse Event Report: NEVRO CORP. HF 10 SENZA; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	NIPG1500
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Codes	Pain (1994); Swelling (2091)
Date of Event	11/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
I was performing my physical therapy exercises.I began having pain at the area of the ipg.The pressure was great around and beneath the ipg.I continued my physical therapy as instructed and performed successfully since 2017.Each time i performed my pt exercises the pressure would increase and then sharp pains would accompany the pressure.The swelling at the ipg increased.It is important to note that the device has been turned off since (b)(6) 2019.There has been no testing relative to the implant.I was contacted by the nevro, director of post market quality, (b)(6) who stated that nevro would not abandon me and would fund the explant.I mailed him correspondence and asked questions and also asked that he confirms, in writing, what the offered via telephone.I have yet to receive correspondence from mr (b)(6) or the neurosurgeon who performed the implant surgery.My concern is that the pain i am experiencing is preventing me from performing physical therapy that helps me manage my pain.The device has been turned off since (b)(6) 2019.The implant is not serving me.In fact, it is causing me pain and interrupting my performing physical therapy which is the activity my dr has prescribed as it helps me manage both pain and mobility issues.I am also making effort to return to work to support myself and this pain is impacting that effort as well.Pain at the ipg site.Fda safety report id# (b)(4).

• Brand Name: HF 10 SENZA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO CORP.
• MDR Report Key: 9818010
• Report Number: MW5093655
• Device Sequence Number: 10745858
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 03/08/2020

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: No Information
• Device Model Number: NIPG1500
• Device Catalogue Number: NIPG1500
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability
• Patient Age: 62 YR
• Patient Weight: 88