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); Patient Problem/Medical Problem (2688)

Event Date 08/02/2016

Event Type  Injury  

Manufacturer Narrative

Nevro had been trying to obtain additional information regarding the details of this case.Nevro is awaiting for the patient's appointment with the physician.

Event Description

During a follow up call, patient informed nevro that after the implant procedure, upon review of the x-rays, physician had stated that the leads were placed incorrectly.The patient was hospitalized for a few days after the implant procedure for swelling, difficulty in breathing and urinating, among other symptoms.The patient was advised to turn off the stimulation.Stimulation was turned back on later.The patient was discharged from the hospital and resumed normal activities.The patient declined to state current status.

Manufacturer Narrative

The device has not been explanted.Nevro had been following up with the patient and was informed that the patient's treating physician has left the practice.At this time, the stimulation is off and the patient is managing the chronic pain with medications.The reported issues had not recurred with stimulation off.Currently, there is no additional information regarding the patient's conditions until the patient finds a new pain physician and obtain insurance approval.

• 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: 6421090
• MDR Text Key: 70458270
• Report Number: 3008514029-2017-00047
• 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,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/01/2018
• Device Model Number: NIPG1500
• Device Catalogue Number: NIPG1500
• Device Lot Number: 9437104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2017
• Initial Date FDA Received: 03/21/2017
• Supplement Dates Manufacturer Received: 02/23/2017
• Supplement Dates FDA Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2016
• 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: 37 YR