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

Model Number	ACCK8012-70
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Nevro is awaiting the return of the stylet.The lead remains implanted.The manufacturing records were reviewed and no non-conformities were found.
Event or Problem Description
It was reported to nevro that the stylet tip broke off when the stylet was removed from the lead during an implant procedure.The physician was able to remove the stylet tip without incident.No injuries were sustained by the patient.The procedure was completed with no further reports of complications and the patient is currently receiving effective pain relief from the device.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection of the returned device confirmed that the hub was no longer attached to the stylet.Functional testing was performed and the device operated to specifications.Since the lead was not returned the root cause could not be determined.The manufacturing records were reviewed and no nonconformities were found.

• Brand Name: SENZA
• Common Device Name: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 7844968
• Report Number: 3008514029-2018-00381
• Device Sequence Number: 1980453
• Product Code: LGW
• UDI-Device Identifier: 00813426020312
• UDI-Public: 00813426020312
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2018

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: Health Professional
• Device Expiration Date: 04/16/2021
• Device Model Number: ACCK8012-70
• Device Catalogue Number: ACCK8012-70
• Device Lot Number: 94424814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1