MAUDE Adverse Event Report: NEVRO CORP SENZA; NEVRO SENZA

Model Number ACCK1015

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Nevro is awaiting for the return of the device.

Event Description

It was reported to nevro that the insertion needle detached from the hub during a trial procedure.It occurred when the physician was removing the needle following lead placement.The physician was able to remove the insertion needle without any injuries to patient.The trial was completed with no further report of complication.

Manufacturer Narrative

Follow-up report indicated that the device will not be returned.The detachment of the insertion needle from the hub was determined to be a manufacturing issue, which was identified and addressed with the manufacturer.The risk analysis demonstrated that the likelihood of occurrence is remote and has minimal impact to the patient's safety.

• 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: 6684274
• MDR Text Key: 79135064
• Report Number: 3008514029-2017-00158
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020183
• UDI-Public: 00813426020183
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/09/2019
• Device Model Number: ACCK1015
• Device Catalogue Number: ACCK1015
• Device Lot Number: 9438018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2016
• 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 Age: 44 YR