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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 Problem Sepsis (2067)
Event Date 10/11/2020
Event Type  Injury  
Manufacturer Narrative

The manufacturing and sterilization records were reviewed, and no non-conformities were found related to the nature of the complaint. The device was not removed.

 
Event Description

It was reported to nevro that the patient acquired an infection resulting in sepsis. The patient was hospitalized and given antibiotics. Nevro attempted to obtain additional information regarding the nature of the infection, but none was available. The patient has recovered without sequelae and continues to use therapy with effective pain relief.

 
Manufacturer Narrative

This report is to update sections based on new information received by nevro. The device was not returned.

 
Event Description

Follow-up indicated that the device was removed. There have been no reports of further complications regarding this event.

 
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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 Key10778838
MDR Text Key214351429
Report Number3008514029-2020-00776
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 09/07/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2020
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 Number9446366
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 Received10/14/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/16/2020
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: 11/03/2020 Patient Sequence Number: 1
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