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 Patient Problem/Medical Problem (2688)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to nevro that two days after activation of therapy, a patient with type-1 diabetes and complex regional pain syndrome experienced fluctuations in blood glucose levels.The patient became hypoglycemic four to five times a day.Therapy was turned off and the fluctuations in blood glucose levels subsided.Subsequently, therapy was turned on, and the fluctuations in blood glucose levels returned.The physician and diabetologist decided to adjust the patient's insulin units for the blood glucose, which mitigated the fluctuations.Follow-up report indicated that the physician does not believe that the fluctuations in blood sugar were device related.The patient is receiving good pain relief and there were no reports of further complications.

• 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: 7116209
• MDR Text Key: 94788665
• Report Number: 3008514029-2017-00360
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/12/2019
• Device Model Number: NIPG1500
• Device Catalogue Number: NIPG1500
• Device Lot Number: 9439813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2017
• 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