MAUDE Adverse Event Report: NEVRO CORP SENZA; NEVRO SENZA

Model Number TLEAD1058-50B

Device Problems Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2015

Event Type  malfunction  

Event Description

A case involving a patient with difficult anatomy was reported to nevro.The patient has extensive fusion from l1 to l5.The physician placed the first lead without incident.When he placed the second lead, he went in at a steep angle and the lead got stuck.The physician decided to explant this second lead, and with effort, he was able to remove the lead.However, the contact separated and remained inside the body.The physician also indicated that he may remove the lead tip when the patient comes back for the permanent implant.The nevro representative followed up with the patient.The patient is doing well but having some significant pain from the procedure.The patient's usual back pain is decreased from 10 to 6 and left leg pain from 5 to 4.Overall, pain relief is 40%.It was also reported that the patient has not been taking her medication on schedule.The physician did address the electrode fragment with the patient and said he would explant it during the implant procedure if needed.

Manufacturer Narrative

Visual inspection of the returned lead found the lead tip separated from the lead body.Microscope inspection of the detached electrode showed a narrow indentation on the proximal end of the electrode.This indentation is indicative of the lead tip being caught on a sharp edge most likely the edge of the insertion needle.Unable to easily remove the lead the user forced the lead through the needle causing the separation.This is evidenced by the necking and factures of the leads observed under the microscope.This appears to be a unique event and will be monitored for any developing trend.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: vis ayer ; 1800 bridge parkway; redwood city, CA 94065 ; 6504333213
• MDR Report Key: 5112454
• MDR Text Key: 27105114
• Report Number: 3008514029-2015-00002
• 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: Other
• Type of Report: Followup
• Report Date: 09/26/2015

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: Physician
• Device Expiration Date: 04/27/2018
• Device Model Number: TLEAD1058-50B
• Device Lot Number: 9435064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2015
• 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