MAUDE Adverse Event Report: NEVRO CORP SENZA; NEVRO SENZA

Model Number	ACCK1015
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nevro is awaiting for the return of the device.
Event or Problem Description
It was reported to nevro that the insertion needle detached from the hub during a trial procedure.It occurred when the physician was removing the needle following lead placement.The physician was able to remove the insertion needle without any injuries to patient.The trial was completed with no further report of complication.
Additional Manufacturer Narrative
Follow-up report indicated that the device will not be returned.The detachment of the insertion needle from the hub was determined to be a manufacturing issue, which was identified and addressed with the manufacturer.The risk analysis demonstrated that the likelihood of occurrence is remote and has minimal impact to the patient's safety.

• Brand Name: SENZA
• Common Device Name: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 6684274
• Report Number: 3008514029-2017-00158
• Device Sequence Number: 16636981
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 08/09/2019
• Device Model Number: ACCK1015
• Device Catalogue Number: ACCK1015
• Device Lot Number: 9438018
• 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: 06/07/2017
• Supplement Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 07/03/2017
• Supplement Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR