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 04/30/2019

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 trial procedure, the physician encountered resistance while placing a lead, possibly due to scar tissue, resulting in two electrodes becoming detached from the lead.There were no injuries to the patient and the physician decided to leave the detached electrodes in place.The patient completed the trial with effective pain relief and the physician plans to remove the detached electrodes during the permanent implant procedure.

Manufacturer Narrative

Follow-up indicated the patient had the permanent implant procedure and the detached electrodes were removed.The patient is currently using their implanted device with complete pain relief.The lead was returned for analysis.Two metal electrodes were missing on the distal end of the lead and a conductor wire was protruding.A knick was found at the lead tip and an indentation was observed on the lead body.Sem analysis showed each of the frayed wire strands were consistently necked and fractured.The indentation on the lead body and knick found on the tip indicate it was likely caught on a sharp edge.The morphology indicates that this was likely caused by a sharpened tip of an insertion needle.A needle likely caught the surface of the lead during lead withdrawal, leading to a cut along the surface up to the missing electrodes.A significant amount of force was then applied, ultimately leading to the detachment of the metal part of the two contacts.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 8652133
• MDR Text Key: 146484959
• Report Number: 3008514029-2019-00207
• 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: 08/01/2019

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: 11/19/2021
• Device Model Number: TLEAD1058-70B
• Device Catalogue Number: TLEAD1058-70B
• Device Lot Number: 94439348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR