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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEVRO CORP. NEVRO SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
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NEVRO CORP. NEVRO SPINAL CORD STIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number NIPG1500
Device Problems Defective Device (2588); Material Deformation (2976); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Failure of Implant (1924)
Event Date 04/04/2018
Event Type  Injury  
Event Description
Spinal cord stimulator implanted on (b)(6) 2017, device model name nipg1500, serial number (b)(4).On (b)(6) 2018 stimulator was not working properly, dr.(b)(6) determined a defective bracket that held the lead caused the spinal cord stimulator to malfunction, causing the stimulator to stop working.Surgery on (b)(6) 2018 for the removal of lead, battery, and bracket and replacement of lead, model, lead1058-50b, serial number (b)(4) (see attached pictures of compressed lead that was removed and the defective bracket).Then, in 2020 discovered one lead of the spinal cords stimulator was not working again, required additional surgery and replacement.Decided to seek other consultation, dr.(b)(6), (b)(6) institute performed surgery on (b)(6) 2020 to remove the spinal cord stimulator and lumbar spinal fusion.Another surgery was required on (b)(6) 2020 after the spinal fusion for the removal of disk herniation.Fda safety report id # (b)(4).
 
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Brand Name
NEVRO SPINAL CORD STIMULATOR
Type of Device
STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
NEVRO CORP.
MDR Report Key12136670
MDR Text Key260749272
Report NumberMW5102365
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 07/04/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberNIPG1500
Device Catalogue NumberNIPG1500
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age45 YR
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