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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 LEAD3005-50B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/09/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was not explanted.The manufacturing records were reviewed and no non-conformities were found.
 
Event or Problem Description
It was reported to nevro that shortly after a lead revision, the patient experienced a burning stomach pain.As a consequence, the patient was admitted to the hospital.Notes from the procedure did not indicate any incidents, but the physician speculated there may have been pressure on the spinal cord.Follow-up indicated that the patient is currently using the device to find effective therapy.
 
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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 Key7879488
Report Number3008514029-2018-00390
Device Sequence Number16663253
Product Code LGW
UDI-Device Identifier00813426020398
UDI-Public00813426020398
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 Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/14/2018
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 Health Professional
Device Expiration Date12/04/2020
Device Model NumberLEAD3005-50B
Device Lot Number94415871
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/17/2018
Initial Report FDA Received Date09/14/2018
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 Age50 YR
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