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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEVRO CORP. SENZA; NEVRO SENZA
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NEVRO CORP. SENZA; NEVRO SENZA Back to Search Results
Model Number LEAD3005-70B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Nerve Damage (1979); Pain (1994)
Date of Event 01/22/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not been explanted yet.The manufacturing records were reviewed and no non-conformities were found.
 
Event or Problem Description
It was reported to nevro that the patient developed a new foot pain after implant.The patient alleged there was nerve damage.The implanting physician believes the pain was due to the physical placement of the leads and was not aware of any nerve damage.The patient had used the device to receive effective pain relief; however, has scheduled to explant the device.
 
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Brand Name
SENZA
Common Device Name
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
MDR Report Key8209003
Report Number3008514029-2018-00564
Device Sequence Number13867269
Product Code LGW
UDI-Device Identifier00813426020404
UDI-Public00813426020404
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P130022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/02/2019
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? No
Operator of Device Health Professional
Device Expiration Date07/27/2020
Device Model NumberLEAD3005-70B
Device Lot Number94406361
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/06/2018
Initial Report FDA Received Date01/02/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age67 YR
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