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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 06/13/2018
Event Type  Injury  
Manufacturer Narrative
The device was explanted but not returned.The manufacturing records were reviewed and no non-conformities were found.
 
Event Description
It was reported to nevro that the device was explanted due to a suspected infection.However, the culture report was negative for infection.The physician believes the patient had an allergic reaction to a powder used during the implant procedure.There have been no reports of further complications regarding this event.
 
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Brand Name
SENZA
Type of Device
NEVRO 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 Key7680196
MDR Text Key113741304
Report Number3008514029-2018-00302
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020015
UDI-Public00813426020015
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 Non-Healthcare Professional
Type of Report Initial
Report Date 07/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/06/2020
Device Model NumberNIPG1500
Device Catalogue NumberNIPG1500
Device Lot Number9441949
Was Device Available for Evaluation? No
Date Manufacturer Received06/13/2018
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 Sequence Number1
Patient Outcome(s) Other;
Patient Age62 YR
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