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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Reaction (2414)
Event Date 06/07/2018
Event Type  Injury  
Manufacturer Narrative
The device was not explanted. The manufacturing records were reviewed and no non-conformities were found. Based on the report, it is likely that the event was related to the procedure.
 
Event Description
It was reported to nevro that the patient was admitted to a rehabilitation facility after implant. The patient indicated it was due to the anesthesia used during the implant procedure. Nevro attempted to obtain the physician's medical assessment regarding the nature of the symptoms but was unsuccessful. The patient has recovered without sequelae and is currently using the device to find effective therapy.
 
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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 Key8061406
MDR Text Key126933169
Report Number3008514029-2018-00482
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 11/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/06/2020
Device Model NumberNIPG1500
Device Catalogue NumberNIPG1500
Device Lot Number9441949
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2018
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: 11/12/2018 Patient Sequence Number: 1
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