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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 MADP2008-25B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/14/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was explanted, but was not returned.Nevro attempted to obtain event details; however, additional information was not available.The manufacturing and sterilization records were reviewed for all implanted devices and no nonconformities were found.
 
Event or Problem Description
It was reported to nevro that a patient presented to the hospital due to an infection.The patient was provided with iv antibiotics and the device was explanted.There were no reports of further complications.
 
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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 Key7336543
Report Number3008514029-2018-00159
Device Sequence Number19136074
Product Code LGW
UDI-Device Identifier00813426020107
UDI-Public00813426020107
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 Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/13/2018
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 Physician
Device Expiration Date04/28/2020
Device Model NumberMADP2008-25B
Device Catalogue NumberMADP2008-25B
Device Lot Number94400532
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 02/16/2018
Initial Report FDA Received Date03/13/2018
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 Age51 YR
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