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

Model Number LEAD1058-70B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994); Spinal Cord Injury (2432)

Event Date 09/27/2018

Event Type  Injury  

Manufacturer Narrative

The device was not explanted.The manufacturing records were reviewed and no non-conformities related to the nature of the complaint were found.Based on the report, it is likely that the event was related to the procedure.

Event Description

It was reported to nevro that during the lead placement, a dural tear occurred.The patient developed incontinence and left foot pain.The patient was subsequently hospitalized for a spinal cord injury and transferred to a rehabilitation center.Follow-up indicated that the patient is feeling better and is expected to make a full recovery.There have been no reports of further complications regarding this event.

Manufacturer Narrative

Follow-up indicated that the patient is still recovering in a rehabilitation center.The patient's incontinence has improved and the patient is currently receiving effective pain relief from the device.There have been no reports of further complications regarding this event.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: catherine aronson ; 1800 bridge parkway; redwood city, CA 94065 ; 6504333218
• MDR Report Key: 8028098
• MDR Text Key: 125783606
• Report Number: 3008514029-2018-00458
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020046
• UDI-Public: 00813426020046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: LEAD1058-70B
• Device Catalogue Number: LEAD1058-70B
• Device Lot Number: 94432805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other