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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEVRO CORPORATION SENZA; NEVRO SENZA
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NEVRO CORPORATION 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 Death (1802)
Date of Event 12/01/2015
Type of Reportable Event Death
Additional Manufacturer Narrative
The device was not returned to nevro for investigation.The manufacturing records were reviewed and no non-conformities were found.
 
Event or Problem Description
It was reported to nevro that the patient had passed away about two years after implant.The patient's co-morbidities included ischemic heart disease and an abdominal aortic aneurysm.Prior to the patient's passing, the patient had been admitted to a hospital on numerous occasions with falls, shortness of breath and issues related to congestive cardiac failure.Nevro had attempted to obtain a medical assessment from the implanting physician but no additional information was available.
 
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Brand Name
SENZA
Common Device Name
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORPORATION
1800 bridge parkway
redwood city CA 94065
MDR Report Key7202670
Report Number3008514029-2018-00051
Device Sequence Number13707201
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 Year2013
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/17/2018
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 Date08/27/2014
Device Model NumberNIPG1000
Device Catalogue NumberNIPG1000
Device Lot Number9427823
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 07/05/2017
Initial Report FDA Received Date01/17/2018
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 Death;
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