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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 07/27/2021
Event Type  Death  
Manufacturer Narrative

The manufacturing records were reviewed and no issues were found. A review of the available diagnostic data showed no indications of a device malfunction. The device was not available for return.

 
Event Description

It was reported to nevro that the patient passed away due to a stroke. There were no reports of issues related to the implanted device from the patient prior to the passing. Nevro attempted to confirm the cause of death from a healthcare professional but no additional information was available.

 
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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 Key12374199
MDR Text Key268358083
Report Number3008514029-2021-00344
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 08/26/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/07/2021
Device MODEL NumberNIPG2000
Device Catalogue NumberNIPG2000
Device LOT Number9444487
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 Received07/30/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/07/2019
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: 08/26/2021 Patient Sequence Number: 1
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