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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 LEAD1058-90B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Cerebrospinal Fluid Leakage (1772); Headache (1880)
Date of Event 08/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The manufacturing records were reviewed and no relevant nonconformities were found.
 
Event or Problem Description
It was reported that the patient experienced headaches when the stimulation was turned on.There was also a report of a cerebrospinal fluid leakage that resolved on its own.The physician decided to remove the device and there have been no reports of further complications regarding this event.
 
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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 Key12334703
Report Number3008514029-2021-00327
Device Sequence Number14460583
Product Code LGW
UDI-Device Identifier00813426020053
UDI-Public00813426020053
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 Year2021
Device Explanted Year2021
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) 08/17/2021
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 Date02/11/2023
Device Model NumberLEAD1058-90B
Device Catalogue NumberLEAD1058-90B
Device Lot Number94467851
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 08/04/2021
Initial Report FDA Received Date08/17/2021
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;
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