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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 LEAD1058-90B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Neurological Deficit/Dysfunction (1982)
Date of Event 11/19/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The manufacturing records were reviewed and no relevant nonconformities were found.
 
Event or Problem Description
It was reported to nevro that the patient developed an issue with neuromonitoring during the implant procedure.The physician chose to abort the procedure and the patient was successfully implanted at a later date.
 
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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 Key11069778
Report Number3008514029-2020-00836
Device Sequence Number14267906
Product Code LGW
UDI-Device Identifier00813426020053
UDI-Public00813426020053
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
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/23/2020
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? No
Operator of Device Health Professional
Device Expiration Date05/21/2022
Device Model NumberLEAD1058-90B
Device Catalogue NumberLEAD1058-90B
Device Lot Number94450711
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/03/2020
Initial Report FDA Received Date12/23/2020
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 Age38 YR
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