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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 Abscess (1690); Unspecified Infection (1930); Paralysis (1997)
Event Date 05/18/2021
Event Type  Injury  
Manufacturer Narrative

The manufacturing and sterilization records were reviewed, and no relevant nonconformities were found. The device was not returned.

 
Event Description

It was reported to nevro that the patient acquired an infection resulting in an epidural abscess and loss of leg function. Nevro attempted to obtain additional information regarding the nature of the issue, but none was available. The abscess was decompressed and the device was removed.

 
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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 Key12025723
MDR Text Key257148840
Report Number3008514029-2021-00219
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP130022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 06/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/18/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberNIPG2500
Device Catalogue NumberNIPG2500
Device LOT Number9448939
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 Received05/24/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/18/2020
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: 06/18/2021 Patient Sequence Number: 1
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