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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 Problem Seroma (2069)
Event Date 07/22/2021
Event Type  Injury  
Manufacturer Narrative

The manufacturing 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 a seroma at the incision site. The physician drained the seroma, after which it filled back up. The physician believes the seroma will resolve on its own this time 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 Key12345616
MDR Text Key267425493
Report Number3008514029-2021-00331
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 08/19/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2021
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 Received07/22/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/19/2021 Patient Sequence Number: 1
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