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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 Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 08/23/2021
Event Type  Injury  
Manufacturer Narrative
The device was returned and the device investigation is in progress. The manufacturing records were reviewed and no relevant nonconformities were found.
 
Event Description
It was reported to nevro that the patient's device was 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 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 device's diagnostic data also showed no evidence of a device malfunction. The manufacturing records were reviewed and no relevant nonconformities were found.
 
Event Description
The returned device was 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 Key12511101
MDR Text Key272645541
Report Number3008514029-2021-00406
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130022
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2017
Device Model NumberNIPG1500
Device Catalogue NumberNIPG1500
Device Lot Number9436012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/23/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/28/2015
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: 09/22/2021 Patient Sequence Number: 1
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