MAUDE Adverse Event Report: NEVRO CORP. SCS WITH PADDLE; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NIPG2500

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994)

Event Date 02/01/2021

Event Type  Injury  

Event Description

Debilitating pain; i had a spinal cord stimulator implanted with leads and paddle in hopes to relieve my sciatica.The post op pain was far worse than explained.Two weeks after surgery i had number 10 pain with pins and needle sensation in groin and down my thigh.My surgeons office promised a rushed mri which, still has not happened.It kept getting postponed.Two months later, my pain is severe and i do have appt for mri on april 19th.I fear having this as no one in my area does then due to risk.I want this removed.I have a referral for a surgeon who i'd like to remove it.I will not return to surgeon who made false promises.Frustrated about the referral not moving forward.I am in so much pain, life is just terrible.Thank you for making me aware.I thought i did my homework before getting the implant, but apparently not.Worth mentioning i have had many tests ruling out the source of pain.Everything checks out fine.Any suggestions? (b)(6).Fda safety report id# (b)(4).

• Brand Name: SCS WITH PADDLE
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): NEVRO CORP.
• MDR Report Key: 11663959
• MDR Text Key: 245578003
• Report Number: MW5100758
• Device Sequence Number: 1
• Product Code: LGW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/11/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NIPG2500
• Device Lot Number: 175933
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 68 YR
• Patient Weight: 50