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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 Unspecified Infection (1930)
Event Date 06/21/2022
Event Type  Injury  
Event Description
It was reported that the patient acquired an infection.The physician is unsure what caused the infection.The physician performed a wound washout and removed the device.There have been no reports of further complications regarding this event.
 
Manufacturer Narrative
The manufacturing and sterilization records were reviewed, and no relevant nonconformities were found.The device was not removed.
 
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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
vis ayer
1800 bridge parkway
redwood city, CA 94065
6504333213
MDR Report Key15069549
MDR Text Key296288121
Report Number3008514029-2022-00352
Device Sequence Number1
Product Code LGW
UDI-Device Identifier00813426020602
UDI-Public00813426020602
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 Other
Type of Report Initial
Report Date 07/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2022
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 Number9451337
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2022
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 SexMale
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