MAUDE Adverse Event Report: NEVRO CORP SENZA; NEVRO SENZA

Model Number NIPG1500

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

Patient Problems Vertigo (2134); Blurred Vision (2137); Weakness (2145); Dizziness (2194)

Event Date 03/08/2017

Event Type  Injury  

Manufacturer Narrative

The device was not explanted.The manufacturing records were reviewed and no nonconformities were found.The device was not explanted.

Event Description

It was reported to nevro that a patient was experiencing weakness, blurry vision and dizziness following an implant procedure.The patient was hospitalized and was diagnosed with vertigo.Vertigo was resolved, however dizziness symptom is still present and is being monitored by the physician.Physician suspected that it could be stroke related, but ct and mri scans did not find any association.Follow up report indicated that patient reported pain relief from hf10 therapy.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: rey nossa ; 1800 bridge parkway; redwood city, CA 94065 ; 6504332742
• MDR Report Key: 6571231
• MDR Text Key: 75307254
• Report Number: 3008514029-2017-00118
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020015
• UDI-Public: 00813426020015
• 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: Other
• Type of Report: Initial
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/26/2018
• Device Model Number: NIPG1500
• Device Lot Number: 9438154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2016
• 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
• Patient Age: 80 YR