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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 Codes Hematoma (1884); Paralysis (1997)
Date of Event 08/25/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The lead was explanted but not returned.The manufacturing records were reviewed and no non-conformities were found.
 
Event or Problem Description
It was reported to nevro that a few days after the implant procedure, the patient developed temporary paralysis in the legs.The patient was hospitalized and subsequently the physician explanted only the lead.During explant the physician found an epidural hematoma.The patient was doing physical therapy and regaining movement in the legs.Follow-up indicated that the patient was discharged home and is able to walk with a walker.
 
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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 Key7904288
Report Number3008514029-2018-00393
Device Sequence Number13495211
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
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/24/2018
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 Health Professional
Device Expiration Date03/06/2021
Device Model NumberLEAD3005-50B
Device Lot Number94421771
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/27/2018
Initial Report FDA Received Date09/24/2018
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 Age77 YR
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