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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 Burning Sensation (2146); Reaction (2414); Electric Shock (2554)
Event Date 09/20/2019
Event Type  Injury  
Manufacturer Narrative
Nevro is awaiting the return of the device. The manufacturing records were reviewed and no issues were found related to the nature of the complaint.
 
Event Description
It was reported to nevro that the patient experienced shocking and a burning sensation at the pocket site while stimulation was on. The device was removed and 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 Key9199098
MDR Text Key162619362
Report Number3008514029-2019-00435
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,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/07/2020
Device Model NumberNIPG1500
Device Catalogue NumberNIPG1500
Device Lot Number9443309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/07/2018
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: 10/16/2019 Patient Sequence Number: 1
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