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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 Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 03/05/2021
Event Type  Injury  
Manufacturer Narrative

The manufacturing records were reviewed and no relevant nonconformities were found. Nevro is awaiting the return of the device.

 
Event Description

It was reported to nevro that the patient had the device removed. Nevro attempted to obtain additional information regarding the nature of the device removal but none was available. There were no reports of device-related issues from the patient prior to the device removal.

 
Manufacturer Narrative

The device was returned and analyzed. Visual inspection of the returned device did not find any anomaly. Functional testing was performed and the device operated to specifications. Review of the patient's diagnostic data also showed no evidence of a device malfunction. The manufacturing records were reviewed and no non-conformities were found.

 
Event Description

The device was returned and analyzed.

 
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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 Key11599509
MDR Text Key243317967
Report Number3008514029-2021-00122
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 05/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/07/2018
Device MODEL NumberNIPG1500
Device Catalogue NumberNIPG1500
Device LOT Number9436680
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/14/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/05/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/07/2016
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: 03/31/2021 Patient Sequence Number: 1
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