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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 Cerebrospinal Fluid Leakage (1772)
Date of Event 12/21/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was not explanted.The manufacturing records were reviewed and no non-conformities were found.
 
Event or Problem Description
It was reported to nevro that the patient received a blood patch due to a suspected leakage of cerebrospinal fluid.The patient had been experiencing headaches, however, these symptoms were noted to be pre-existing and present prior to implant.Nevro attempted to obtain a medical assessment regarding the nature of the symptoms but was unsuccessful.There were no reported device-related issues from the patient prior to this incident and the patient continues to use the device to find effective pain relief.
 
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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 Key8262918
Report Number3008514029-2019-00028
Device Sequence Number2462977
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 Year2016
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 01/18/2019
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 Date07/24/2018
Device Model NumberMADP2008-25B
Device Catalogue NumberMADP2008-25B
Device Lot Number9435753
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/22/2018
Initial Report FDA Received Date01/18/2019
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 Age71 YR
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