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

Model Number LEAD1058-50B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/25/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to nevro that the patient¿s permanent implant procedure was aborted due to excessive bleeding at the incision sites.It was noted the patient had not quit taking aspirin prior to the procedure.The patient recovered without sequelae and was cleared for future surgery by a hematologist.The patient has been rescheduled for implant.

• 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: 9349124
• MDR Text Key: 167207271
• Report Number: 3008514029-2019-00493
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2022
• Device Model Number: LEAD1058-50B
• Device Catalogue Number: LEAD1058-50B
• Device Lot Number: 94454506
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2019
• 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