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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEVRO CORPORATION SENZA; NEVRO SENZA
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NEVRO CORPORATION SENZA; NEVRO SENZA Back to Search Results
Model Number MADP2008-25B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 02/01/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was explanted but was not returned.The manufacturing and sterilization records were reviewed and no non-conformities were found.
 
Event or Problem Description
It was reported to nevro that a patient had acquired an infection at the lead incision site.The wound was packed with silver and the patient was prescribed oral antibiotics.There have been no further reports of complications.
 
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Brand Name
SENZA
Common Device Name
NEVRO SENZA
Manufacturer (Section D)
NEVRO CORPORATION
1800 bridge parkway
redwood city CA 94065
MDR Report Key7217597
Report Number3008514029-2018-00099
Device Sequence Number13710246
Product Code LGW
UDI-Device Identifier00813426020107
UDI-Public00813426020107
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 Year2016
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/24/2018
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 Physician
Device Expiration Date01/04/2019
Device Model NumberMADP2008-25B
Device Catalogue NumberMADP2008-25B
Device Lot Number9436683
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 03/22/2017
Initial Report FDA Received Date01/24/2018
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 Age55 YR
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