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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 Pain (1994)
Date of Event 09/28/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The manufacturing records were reviewed and no issues were found.H3 other text : the device was not available for return.
 
Event or Problem Description
It was reported to nevro that the patient developed pain due to the leads pressing on a nerve root.The device was removed and the patient will be scheduled for surgical paddle lead in the future.
 
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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 Key10736909
Report Number3008514029-2020-00766
Device Sequence Number4123054
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
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/26/2020
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 Date04/23/2022
Device Model NumberLEAD1058-90B
Device Catalogue NumberLEAD1058-90B
Device Lot Number94449162
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 10/01/2020
Initial Report FDA Received Date10/26/2020
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;
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