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

Model Number NIPG2500

Device Problems Defibrillation/Stimulation Problem (1573); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing records were reviewed and no relevant nonconformities were found.A review of the device's diagnostic data shows no indication of a malfunction.Nevro is anticipating the return of the device.

Event Description

It was reported to nevro that the patient experienced pain, headaches and a "shocking sensation" with therapy on and off.The device was removed and there have been no reports of further complications regarding this event.

Manufacturer Narrative

The device was returned and analyzed.Visual inspection of the returned device did not find any anomaly.Functional testing was performed and the device operated to specifications.Review of the patient's diagnostic data also showed no evidence of a device malfunction.The manufacturing records were reviewed and no relevant nonconformities were found.

Event Description

The device was returned and analyzed.

• 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: 11880612
• MDR Text Key: 252637372
• Report Number: 3008514029-2021-00191
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020602
• UDI-Public: 00813426020602
• 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: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: NIPG2500
• Device Catalogue Number: NIPG2500
• Device Lot Number: 9448253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• 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