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

Model Number TLEAD1058-50B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing records were reviewed and no issues were found related to the nature of the complaint.Nevro is awaiting the return of the device.

Event Description

It was reported to nevro that during the trial procedure the most distal electrode detached from the lead into the patient, remaining subcutaneous.No injuries were sustained by the patient.The procedure continued without further incident.The patient finished the trial with effective pain relief and is planning to be implanted with an ipg.There have been no reports of further complications regarding this event.

Manufacturer Narrative

The lead was returned for analysis.The most distal electrode at the tip was missing and the conductor wire was exposed.An insertion needle likely dragged across the surface of the lead during lead withdrawal, which led to the needle catching onto the distal electrode and resulting in fracture of the device.

Event Description

The lead was removed and returned for analysis.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 8931579
• MDR Text Key: 156712583
• Report Number: 3008514029-2019-00341
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020367
• UDI-Public: 00813426020367
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2022
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94442114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR