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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 NIPG1500
Device Problems Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pocket Erosion (2013)
Event Date 01/28/2021
Event Type  Injury  
Manufacturer Narrative

The manufacturing and sterilization records were reviewed and no issues were found.

 
Event Description

It was reported to nevro that the ipg was eroding through the skin. The patient developed an infection and the device was removed. Nevro attempted to obtain additional information regarding the nature of the symptoms but was unsuccessful. There have been no reports of further complications regarding this event.

 
Manufacturer Narrative

The device was returned and analyzed. The device was submitted to several tests, and it was not possible to find any abnormalities that could explain the reported condition. The device passed all impedance measurement tests. The manufacturing records were reviewed and no non-conformities were found.

 
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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 Key11406471
MDR Text Key234515461
Report Number3008514029-2021-00086
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,Followup
Report Date 06/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/03/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/20/2021
Device MODEL NumberNIPG1500
Device Catalogue NumberNIPG1500
Device LOT Number9444581
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/22/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/20/2019
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: 03/03/2021 Patient Sequence Number: 1
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