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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 LEAD3005-70B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Neurological Deficit/Dysfunction (1982); Thrombosis (2100)
Date of Event 05/17/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was not explanted.The manufacturing records were reviewed and no nonconformities were found.
 
Event or Problem Description
It was reported to nevro that a patient could not walk and was recently sent home from rehabilitation with medications for nerve pain and anti-coagulant.Nevro tried to obtain additional information however the cause is unknown.It was also reported that the patient had an emergency surgery for gall bladder before implant.Stimulation continues to be on and there have been 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 Key7671050
Report Number3008514029-2018-00307
Device Sequence Number2580120
Product Code LGW
UDI-Device Identifier00813426020404
UDI-Public00813426020404
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
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/09/2018
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 Health Professional
Device Expiration Date10/20/2020
Device Model NumberLEAD3005-70B
Device Lot Number94413103
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/11/2018
Initial Report FDA Received Date07/09/2018
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 Age79 YR
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