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

Model Number NIPG1500

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

Patient Problem Skin Erosion (2075)

Event Date 09/19/2019

Event Type  Injury  

Manufacturer Narrative

Nevro is currently awaiting the return of the device.The manufacturing records were reviewed and no issues were found related to the nature of the complaint.

Event Description

It was reported to nevro that the patient's pocket site opened up.The device was replaced and placed into a new pocket.There have been no reports of further complications regarding this event.The patient is currently using therapy with complete pain relief.

Manufacturer Narrative

Visual inspection of the returned devices did not find any anomaly.Functional testing was performed and the devices 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 nonconformities were found.

Event Description

The system was removed and returned for analysis.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 9194993
• MDR Text Key: 162434946
• Report Number: 3008514029-2019-00431
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020015
• UDI-Public: 00813426020015
• Combination Product (y/n): N
• PMA/PMN Number: P130022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2018
• Device Model Number: NIPG1500
• Device Catalogue Number: NIPG1500
• Device Lot Number: 9437424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other