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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 LEAD1058-70B
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Unspecified Infection (1930)
Event Date 05/24/2021
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported to nevro that the patient acquired an abscess at the incision site. Nevro attempted to obtain additional information regarding the nature of the issue, but none was available. The site was washed out and the patient was given antibiotics. The patient recovered without sequelae.

 
Manufacturer Narrative

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

 
Event Description

Follow-up indicated that the patient developed an infection at the incision site. The physician did not believe this infection to be related to the device. The device was removed 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 Key12045888
MDR Text Key257610138
Report Number3008514029-2021-00228
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 07/07/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/22/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberLEAD1058-70B
Device Catalogue NumberLEAD1058-70B
Device LOT Number94485504
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? No
Date Device Manufactured11/02/2020
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: 06/22/2021 Patient Sequence Number: 1
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