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 Code	Neurological Deficit/Dysfunction (1982)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturing records were reviewed and no issues were found.The device was not removed.
Event or Problem Description
It was reported to nevro that after the lead was revised, the patient was hospitalized due to numbness and difficulty moving the legs.The surgeon does not think the device was causing or exacerbating the symptoms.The patient is currently recovering in a rehabilitation facility.
Additional Manufacturer Narrative
The device was not available for return.
Event or Problem Description
Follow-up indicated that the device was removed.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: 9199684
• Report Number: 3008514029-2019-00437
• Device Sequence Number: 16791621
• 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: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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: 02/05/2022
• Device Model Number: LEAD3005-70B
• Device Catalogue Number: LEAD3005-70B
• Device Lot Number: 94444932
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 07/23/2020
• 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