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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 NIPG2000
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Insufficient Information (4580)
Event Date 07/19/2021
Event Type  Injury  
Manufacturer Narrative

Analysis of the device is currently in progress. The manufacturing records were reviewed and no issues were found.

 
Event Description

It was reported to nevro that the patient had their device removed. Nevro attempted to obtain additional information regarding the device removal but was unsuccessful.

 
Manufacturer Narrative

The analysis of the returned device was completed. Visual inspection of the returned device did not find any anomaly. Functional testing was performed and the device operated to specifications. A review of the patient's diagnostic data also showed no evidence of a device malfunction. The manufacturing records were reviewed and no relevant nonconformities were found.

 
Event Description

Follow-up indicated that the patient requested the device to be removed due to preferring a pain pump.

 
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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 Key12316697
MDR Text Key266360244
Report Number3008514029-2021-00321
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 08/12/2021
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 EXPIRATION Date09/10/2021
Device MODEL NumberNIPG2000
Device Catalogue NumberNIPG2000
Device LOT Number9445752
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/19/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/10/2019
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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