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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 NIPG2500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Paralysis (1997)
Event Date 08/02/2021
Event Type  Injury  
Manufacturer Narrative

The manufacturing records were reviewed and no issues were found.

 
Event Description

It was reported to nevro that shortly after the implant procedure the patient was paralyzed from the waist done. No abnormalities were noted intraoperatively. The device was removed and the patient is recovering in a rehabilitation facility.

 
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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 Key12374200
MDR Text Key268358459
Report Number3008514029-2021-00346
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 MODEL NumberNIPG2500
Device Catalogue NumberNIPG2500
Device LOT Number9449361
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 Received08/02/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/17/2021
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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