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

Model Number NIPG2500

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Burn(s) (1757); Hypersensitivity/Allergic reaction (1907)

Event Date 03/09/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing records were reviewed and no relevant nonconformities were found.A review of the available diagnostic data shows that the temperature of the device was within the expected range.The device was not returned.

Event Description

It was reported to nevro that the patient experienced superficial burn marks at the pocket site.The patient was given antibiotics and wound treatment.The wound healed without sequelae and the patient remains under medical supervision.The patient continues to use the device to find effective pain relief.

Manufacturer Narrative

This report is to update and additional information received by nevro.

Event Description

Follow-up indicated that the physician believed the patient to be allergic to the charging paddle (part of the senza system).The physician instructed the patient to no longer charge directly on the skin.There have been no further reports of burn marks following the physician's instructions.

• 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: 11615923
• MDR Text Key: 243833375
• Report Number: 3008514029-2021-00128
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020572
• UDI-Public: 00813426020572
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2021
• Device Model Number: NIPG2500
• Device Catalogue Number: NIPG2500
• Device Lot Number: 9445975
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2019
• 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