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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 LEAD3005-70B
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Hematoma (1884); Paresis (1998)
Date of Event 10/05/2018
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 the patient developed an epidural hematoma shortly after the implant procedure and the patient experienced partial paralysis of the lower extremities.The lead was removed out of the epidural space and placed into the subcutaneous tissue.Surgical decompression was performed, the lead was placed back into the epidural space, and the patient was transferred to a rehabilitation unit.Follow-up indicated that the patient has recovered and is currently using the device 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 Key8044780
Report Number3008514029-2018-00470
Device Sequence Number1499530
Product Code LGW
UDI-Device Identifier00813426020404
UDI-Public00813426020404
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) 11/06/2018
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 Date07/06/2020
Device Model NumberLEAD3005-70B
Device Lot Number94405763
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/09/2018
Initial Report FDA Received Date11/06/2018
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 Age57 YR
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