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

Model Number	TLEAD1058-50B
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The senza hfx trial system physician manual (10001231 rev.B) instructs healthcare providers to keep leads connected to the tsm during the entire trial period.The proximal end of leads should not be disconnected from the tsm until the trial is concluded and the leads are removed.  the manufacturing records were reviewed and no relevant nonconformities were found.   nevro submits this report in compliance with fda's medical device reporting regulations under 21 cfr part 803.Nevro has complied with regulatory investigation requirements and is submitting all information that is reasonably known to us at this time.However, we may not have been able to confirm this information or complete the investigation within the timeframe for filing this report.We may have given no response or an incomplete response to certain questions because we do not currently have information available to provide a complete response.If we later obtain any required information that was not available at the time of this initial report, we will submit a supplemental report.This report is not an admission by anyone that the product described in this report was defective, that it malfunctioned, or that it caused or contributed to the event described in this report.We may conclude that the device had no defect, did not malfunction, or did not cause or contribute to a reportable event.Some of the items on this form include forced-choice terms used by the fda for reporting purposes that do not necessarily reflect nevro¿s conclusions about the causes or nature of the event.This statement should be included with any freedom of information act response. the device was not returned.
Event or Problem Description
It was reported that a patient arrived for a regularly scheduled lead pull and end of their trial on (b)(6) 2022.The healthcare provider delayed the lead pull due to concerns that the patient took aspirin during their trial.On the same day, the healthcare provider disconnected the proximal end of the trial leads from the tsm and taped the proximal ends of the leads to the patient's body under a sterile dressing. after discontinuing the aspirin, the patient returned for the lead pull on (b)(6) 2022 and when the dressing was removed, the leads were not visible.X-ray imaging confirmed that the leads had migrated into the patient's body. the leads were removed via a surgical procedure on (b)(6) 2022 and there have been no reports of further complications regarding this event.The patient has since proceeded to a permanent implant and uses the system to find effective pain relief.

• Brand Name: SENZA
• Common Device Name: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: zulfiqar ali ; 1800 bridge parkway; redwood city, CA 94065 ; 6505317627
• MDR Report Key: 16382616
• Report Number: 3008514029-2023-00075
• Device Sequence Number: 12312322
• Product Code: LGW
• UDI-Device Identifier: 00813426020732
• UDI-Public: 00813426020732
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P130022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: TLEAD1058-50B
• Device Catalogue Number: TLEAD1058-50B
• Device Lot Number: 94526423
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TLEAD1058-50B (LOT 94526423).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male