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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 LEAD2005-90B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 01/15/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The manufacturing and sterilization records were reviewed and no issues were found.The device was not available for return.
 
Event or Problem Description
It was reported that the patient developed an infection at the incision site.Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful.Antibiotics were given and the patient is recovering.The device is currently being used with effective pain relief.
 
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Brand Name
SENZA
Common Device Name
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORP.
1800 bridge parkway
redwood city CA 94065
MDR Report Key11311791
Report Number3008514029-2021-00051
Device Sequence Number715678
Product Code LGW
UDI-Device Identifier00813426020640
UDI-Public00813426020640
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P130022
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date04/30/2023
Device Model NumberLEAD2005-90B
Device Catalogue NumberLEAD2005-90B
Device Lot Number94473622
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/15/2021
Initial Report FDA Received Date02/10/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age50 YR
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