MAUDE Adverse Event Report: NEVRO CORP. SENZA; NEVRO SENZA

Model Number	LEAD3005-70B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection of the returned device did not find any anomaly.Functional testing was performed and the device operated to specifications.The manufacturing records were reviewed and no nonconformities were found.
Event or Problem Description
It was reported to nevro that during the implant procedure, neuromonitoring indicated some neurological deficit.The physician decided not to implant the lead and the patient is currently recovering.There have been no reports of further complications regarding this event and the physician will implant the lead in the future.
Additional Manufacturer Narrative
Follow-up indicated that the patient is still recovering.The ipg remains implanted and leads will be implanted in the future.

• Brand Name: SENZA
• Common Device Name: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 8127371
• Report Number: 3008514029-2018-00508
• Device Sequence Number: 19398487
• Product Code: LGW
• UDI-Device Identifier: 00813426020404
• UDI-Public: 00813426020404
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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 Date: 07/27/2020
• Device Model Number: LEAD3005-70B
• Device Lot Number: 94406362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Supplement Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR