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

Model Number	LEAD3005-70B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was explanted but not returned.The manufacturing and sterilization records were reviewed and no non-conformities were found.
Event or Problem Description
It was reported to nevro that about one month after implant the patient developed an infection at the lead incision site and reported draining of fluid from the incision site.The patient was prescribed antibiotics and given silver dressings.Follow-up indicated that the lead wires were exposed and the physician decided to explant the device.Nevro attempted to obtain additional information regarding the nature of the infection but was unsuccessful.Prior to the explant but the patient had reported receiving effective pain relief from the device.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: 7895778
• Report Number: 3008514029-2018-00404
• Device Sequence Number: 1819161
• Product Code: LGW
• UDI-Device Identifier: 00813426020404
• UDI-Public: 00813426020404
• 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
• 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): 09/20/2018

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: No Information
• Device Expiration Date: 05/17/2020
• Device Model Number: LEAD3005-70B
• Device Lot Number: 94401432
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 09/20/2018
• 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: 71 YR