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

Model Number	LEAD3005-50B
Medical Device Problem Codes	Difficult To Position (1467); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neurological Deficit/Dysfunction (1982)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was explanted but was not returned.The manufacturing records were reviewed and no non-conformities were found.
Event or Problem Description
It was reported to nevro that a trial patient had lost sensation in his legs shortly after the procedure.The physician had experienced difficulty placing the lead.Movement in the lower extremities was regained in about an hour.The patient's leads have subsequently been explanted.There have been no further reports of complications.
Additional Manufacturer Narrative
This follow-up is to correct the initial 3500a.The initial report should be 02-apr-2018.

• Brand Name: SENZA
• Common Device Name: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 7390947
• Report Number: 3008514029-2018-00193
• Device Sequence Number: 1575003
• Product Code: LGW
• UDI-Device Identifier: 00813426020398
• UDI-Public: 00813426020398
• 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
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2018

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: Physician
• Device Expiration Date: 10/10/2020
• Device Model Number: LEAD3005-50B
• Device Lot Number: 94411593
• 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: 02/28/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 05/23/2018
• 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: 80 YR