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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 NIPG2500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paralysis (1997); Thrombosis/Thrombus (4440)
Event Date 12/27/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturing records were reviewed and no relevant nonconformities were found. The device was not returned.
 
Event Description
It was reported to nevro that following the implant procedure, the patient experienced lower body paralysis. The physician determined that a blood clot was the cause of the issues. The patient was hospitalized and the device was removed. The patient is recovering and was transferred to a rehabilitation facility.
 
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Brand NameSENZA
Type of DeviceNEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
Manufacturer Contact
catherine aronson
1800 bridge parkway
redwood city, CA 94065
6504333218
MDR Report Key11203295
MDR Text Key227819859
Report Number3008514029-2021-00026
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNIPG2500
Device Catalogue NumberNIPG2500
Device Lot Number9447006
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/20/2021 Patient Sequence Number: 1
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