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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 NIPG1000
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 05/01/2015
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was not returned.The manufacturing and sterilization records were reviewed and no non-conformities were found.
 
Event or Problem Description
During a routine follow-up, it was reported to nevro that a patient had acquired an infection.The patient was hospitalized and treated with antibiotics.There have been no further reports of 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 Key6749354
Report Number3008514029-2017-00215
Device Sequence Number187600
Product Code LGW
UDI-Device Identifier00813426020008
UDI-Public00813426020008
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 Year2014
Device Explanted Year2015
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/27/2017
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 Date10/02/2015
Device Model NumberNIPG1000
Device Catalogue NumberNIPG1000
Device Lot Number9430979
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 07/06/2017
Initial Report FDA Received Date07/27/2017
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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