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

Model Number TLEAD1058-50B

Device Problems Material Frayed (1262); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

Nevro is awaiting the return of the explanted device.The manufacturing records were reviewed and no non-conformities were found.

Event Description

It was reported to nevro that while removing the leads from a trial patient, the physician encountered resistance, resulting in the detachment of two electrodes.X-rays confirmed the detached components were outside of the epidural space and the physician was not concerned about them affecting the patient's safety and may remove them in the future.There have been no reports of further complications regarding this event.

Manufacturer Narrative

Follow-up indicated that the patient will be implanted with the permanent device and the physician will remove the electrodes during the implant procedure.The physician is not concerned about electrodes affecting the patient's safety.The device was returned and investigated at nevro.Visual examination of the lead found two electrodes were missing and damage on the external layer, exposing the conductor wires on the distal end of the lead.The root cause of the damage is likely due to the surgical procedure when the lead caught on the patient's anatomy while attempting to remove the lead.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
• Manufacturer Contact: catherine aronson ; 1800 bridge parkway; redwood city, CA 94065 ; 6504333218
• MDR Report Key: 8192832
• MDR Text Key: 131333446
• Report Number: 3008514029-2018-00540
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020367
• UDI-Public: 00813426020367
• 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

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/13/2021
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94433493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/13/2018
• 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: 61 YR