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 Device Embedded In Tissue or Plaque (3165)

Event Date 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis of the device is currently in progress.The manufacturing records were reviewed and no issues were found.

Event Description

It was reported to nevro that during the implant procedure, the physician discovered that the anchor that was implanted during the trial had separated into three pieces.The lead and all pieces of the anchor were removed and replaced.No injuries were sustained by the patient and the procedure 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.The manufacturing records were reviewed and no non-conformities were found.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 8592414
• MDR Text Key: 146219543
• Report Number: 3008514029-2019-00176
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020251
• UDI-Public: 00813426020251
• Combination Product (y/n): N
• PMA/PMN Number: P130022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

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: 08/08/2020
• Device Model Number: ACCK5300
• Device Catalogue Number: ACCK5300
• Device Lot Number: 9440692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Manufacturer Received: 04/10/2019
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: 04/10/2019
• Supplement Dates FDA Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR