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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 Problems Hearing Impairment (1881); Unspecified Infection (1930); Impaired Healing (2378)
Event Date 07/06/2022
Event Type  Injury  
Manufacturer Narrative
The manufacturing and sterilization records were reviewed, and no relevant nonconformities were found. Nevro submits this report in compliance with fda¿s medical device reporting regulations under 21 cfr part 803. Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time. However, we may not have been able to confirm this information or complete the investigation within the timeframe for filing this report. We may have given no response or an incomplete response to certain questions because we do not currently have information available to provide a complete response. If we later obtain any required information that was not available at the time of this initial report, we will submit a supplemental report. This report is not an admission by anyone that the product described in this report was defective, that it malfunctioned, or that it caused or contributed to the event described in this report. We may conclude that the device had no defect, did not malfunction, or did not cause or contribute to a reportable event. Some of the items on this form include forced-choice terms used by the fda for reporting purposes that do not necessarily reflect nevro¿s conclusions about the causes or nature of the event. This statement should be included with any freedom of information act response. The device was not returned.
 
Event Description
It was reported that the patient experienced impaired wound healing and infection at the surgical site. 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
vis ayer
1800 bridge parkway
redwood city, CA 94065
6504333213
MDR Report Key15168640
MDR Text Key297311442
Report Number3008514029-2022-00370
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
Type of Report Initial,Followup
Report Date 08/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNIPG2500
Device Catalogue NumberNIPG2500
Device Lot Number9450397
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/05/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/25/2021
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: 08/04/2022 Patient Sequence Number: 1
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