MAUDE Adverse Event Report: NEVRO CORP SENZA; NEVRO

Model Number	ACCK1015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	12/16/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to nevro that a patient was admitted to the hospital due to severe headache post implant.The physician indicated that he had a wet tap using a 6" needle.The patient received a blood patch and the headache was resolved.The report indicated that patient had recovered without sequelae.

• Brand Name: SENZA
• Common Device Name: NEVRO
• Manufacturer (Section D): NEVRO CORP; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 5354104
• Report Number: 3008514029-2016-00003
• Device Sequence Number: 450572
• Product Code: LGW
• UDI-Device Identifier: 00813426020183
• UDI-Public: 00813426020183
• 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: Other
• Report Date (Section B): 01/06/2016

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: 03/16/2018
• Device Model Number: ACCK1015
• Device Lot Number: 9434729
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/08/2016
• 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