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 Swelling (2091); Reaction (2414)

Event Date 08/06/2016

Event Type  Injury  

Manufacturer Narrative

The device is still implanted.There have not been any reports of symptoms recurring.The patient is being programmed and stimulation is on.The manufacturing records were reviewed and no nonconformities were found.Based on the initial information provided, it appears the event was the result of reaction to a new medication prescribed by her doctor.

Event Description

It was reported to nevro that a patient was admitted to the er due to report of swelling in the foot and loss of coordination.The patient was having a reaction to new medication and experienced intense sensation in her head.The patient was given morphine in the er and no other tests were given to the patient.The patient was discharged on the same day.The swelling in the foot was due to reflex sympathetic dystrophy syndrome and it was being addressed with the nevro stimulator.There are no other reports of intense sensation since the patient was discharged from the er.

• 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: 5919208
• MDR Text Key: 53632775
• Report Number: 3008514029-2016-00073
• 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: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/29/2018
• Device Model Number: NIPG1500
• Device Lot Number: 9436797
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• 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: 62 YR