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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 TLEAD1058-50B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Pain (1994)
Event Date 07/18/2021
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 the patient experienced pocket pain and a fever. Nevro attempted to obtain additional information regarding the nature of the issue but none was available. The device was removed and there have been no reports of further complications regarding this event.

 
Manufacturer Narrative

This report is to update based on new information.

 
Event Description

Follow-up indicated that the patient's pocket pain and fever were due to an infection caused by a bandage changed at home. The physician drained the infection and 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 Key12316742
MDR Text Key266368090
Report Number3008514029-2021-00323
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 09/03/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTLEAD1058-50B
Device Catalogue NumberTLEAD1058-50B
Device LOT Number94497169
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 Received07/18/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/20/2021
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: 08/12/2021 Patient Sequence Number: 1
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