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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 Problems Pain (1994); Reaction (2414)
Event Date 06/05/2019
Event Type  Injury  
Manufacturer Narrative
The manufacturing records were reviewed and no issues were found related to the nature of the complaint. The device was removed but not returned.
 
Event Description
It was reported to nevro that the patient believed to be having an allergic reaction to the device, due to experiencing itching and pain. The device was removed and nevro attempted to obtain a medical assessment regarding the nature of the issue but was unsuccessful. There have been no reports of further complications regarding this event.
 
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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 Key9592322
MDR Text Key175083826
Report Number3008514029-2020-00424
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 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/27/2019
Device Model NumberNIPG1500
Device Catalogue NumberNIPG1500
Device Lot Number9441269
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 Received12/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2017
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: 01/15/2020 Patient Sequence Number: 1
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