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

Model Number	LEAD2008-60B
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing and sterilization records were reviewed, and no non-conformities were found related to the nature of the complaint.The device was not available for return.
Event or Problem Description
It was reported to nevro that during the trial, a patient was implanted with a trial lead extension from the hospital¿s inventory.Following the procedure, nevro found that the lead extension was past its expiration date and immediately notified the hospital staff.The implanting physician decided to leave the lead extension in until the permanent implant and closely monitored the patient.The trial ended successfully and without complications.The patient planned to move forward with a permanent implant in the future.Two days after the end of trial, the patient presented with an infection.Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful.The device was removed, and the patient recovered without sequalae.

• Brand Name: SENZA
• Common Device Name: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 9507687
• Report Number: 3008514029-2019-00544
• Device Sequence Number: 1305055
• Product Code: LGW
• UDI-Device Identifier: 00813426020084
• UDI-Public: 00813426020084
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: 04/11/2019
• Device Model Number: LEAD2008-60B
• Device Catalogue Number: LEAD2008-60B
• Device Lot Number: 9437334
• 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: 11/28/2019
• Initial Report FDA Received Date: 12/20/2019
• 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