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

Model Number TLEAD1058-70B

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/14/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturing records were reviewed and no issues were found related to the nature of the complaint.The device was returned and is currently being analyzed.

Event Description

It was reported to nevro that the lead fractured during the implant procedure.The physician believed this was caused by the patient¿s pre-existing spinal stenosis resulting in a tight epidural space.The procedure was aborted and no injuries were sustained by the patient.The physician decided to leave the detached lead fragment in place.

Event Description

The device was returned and analyzed.

Manufacturer Narrative

The device was returned and analyzed.Visual inspection confirmed the most distal electrode was missing from the lead.High magnification of the wire strands showed features consistent with tensile overload failure due to the patient¿s anatomy.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 10041611
• MDR Text Key: 190485409
• Report Number: 3008514029-2020-00550
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020374
• UDI-Public: 00813426020374
• 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: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2022
• Device Model Number: TLEAD1058-70B
• Device Catalogue Number: TLEAD1058-70B
• Device Lot Number: 94451533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR