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U.S. Department of Health and Human Services

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

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NEVRO CORP. SCS WITH PADDLE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
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).
 
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Brand NameSCS WITH PADDLE
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
NEVRO CORP.
MDR Report Key11663959
MDR Text Key245578003
Report NumberMW5100758
Device Sequence Number1
Product Code LGW
Reporter Country CodeUS
Number of Events Reported1
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 Received04/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNIPG2500
Device Lot Number175933
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/13/2021 Patient Sequence Number: 1
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