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

Model Number TLEAD1058-50B

Device Problem Detachment Of Device Component (1104)

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

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

The device was explanted, but was not returned for analysis.The manufacturing records were reviewed and no nonconformities were found.

Event Description

It was reported to nevro that a patient presented to the clinic for a lead removal at the end of a trial procedure.Both leads were explanted; however, the top contact was detached from each lead.The patient experienced good pain relief during the trial and is moving forward with a permanent implant.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: 7153162
• MDR Text Key: 96126965
• Report Number: 3008514029-2017-00372
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020367
• UDI-Public: 00813426020367
• 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: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/14/2020
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94407573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2017
• 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
• Patient Age: 70 YR