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

Model Number LEAD1058-50B

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/31/2018

Event Type  Injury  

Manufacturer Narrative

The device was explanted but not returned.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported to nevro that during the trial procedure, one of the electrode separated from the lead into the subcutaneous tissue.No injuries were sustained by the patient.The lead was removed and the patient started the trial with one lead.The physician believed the electrode separation was due to the patient's anatomy.Since the patient had a successful trial, the physician has decided to remove the electrode during the permanent implant procedure.There have been no reports of further complications regarding this event.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: catherine aronson ; 1800 bridge parkway; redwood city, CA 94065 ; 6504333218
• MDR Report Key: 7637929
• MDR Text Key: 112333293
• Report Number: 3008514029-2018-00275
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020022
• UDI-Public: 00813426020022
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/27/2021
• Device Model Number: LEAD1058-50B
• Device Catalogue Number: LEAD1058-50B
• Device Lot Number: 94421062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2018
• 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: 48 YR