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

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	06/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system was explanted and returned for analysis.Investigation of the paddle lead revealed a fracture on the distal portion of the paddle, likely due to damage sustained during surgery.Functional testing was performed and the devices operated to specifications.Review of the patient's diagnostic data also showed no evidence of a device malfunction.The manufacturing records were reviewed and no nonconformities were found.
Event or Problem Description
It was reported to nevro that the patient developed rib pain and irritable bowel syndrome (ibs) symptoms after implant.Patient continued to experience these symptoms even when the device was turned off and the patient had a history of ibs symptoms.The device was explanted as a result of these symptoms.There have been no reports of further complications regarding this event.

• Brand Name: SENZA
• Common Device Name: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 7954635
• Report Number: 3008514029-2018-00416
• Device Sequence Number: 428447
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2018

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 Date: 03/23/2020
• Device Model Number: LEAD3005-50B
• Device Lot Number: 94397241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2018
• Initial Report FDA Received Date: 10/10/2018
• 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: 61 YR