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

Model Number ACCK5300

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

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

Event Date 11/17/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned but analysis has not been completed yet.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported to nevro that during a revision procedure, the physician discovered that the anchor separated into three pieces.The lead and all pieces of the anchor were removed and no injuries were sustained by the patient.The procedure was completed without further incident.There have been no reports of further complications regarding this event and the patient is currently using their device to find effective pain relief.

Manufacturer Narrative

The device was returned and investigated at nevro.Visual examination of the anchor found the silicone casing torn into two pieces.There were no obvious signs of voids or defects in the molded silicone casing.The edges of the break from the two pieces seemed more indicative of tearing damage.The exact root cause of the damage could not be determined but is likely due to a suture needle that punctured through the silicone casing which propagated a tear.The manufacturing records were reviewed and no non-conformities related to the nature of the complaint were found.

• 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: 8167310
• MDR Text Key: 130631370
• Report Number: 3008514029-2018-00592
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020251
• UDI-Public: 00813426020251
• 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,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2020
• Device Model Number: ACCK5300
• Device Catalogue Number: ACCK5300
• Device Lot Number: 9440569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2018
• Initial Date Manufacturer Received: 11/17/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 11/17/2018
• Supplement Dates FDA Received: 02/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2017
• 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 Age: 43 YR