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

Model Number	ACCK5300
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced pain at the anchor site.The anchor was replaced.The anchor was received damaged with one of the eyelets cut off and missing.The physician didn¿t mention removing it or leaving it in situ during the procedure, however the exact location of the eyelet is unknown.There have been no reports of further complications regarding this event.
Additional Manufacturer Narrative
The device was returned and the device evaluation is in progress.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.
Additional Manufacturer Narrative
Updated b5 + h6 to capture correction that anchor was removed, not replaced.The device was returned and analyzed.The investigation found that one of the anchor¿s silicone loops was torn.Most likely this occurred during the explant procedure, but this cannot be confirmed.It was reported that the patient¿s anchor site pain has since resolved.The source of the pain could not be determined.The investigation found no functional issue with the return lead anchor.  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.
Event or Problem Description
Correction: the anchor was removed, not replaced.

• 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: 16569626
• Report Number: 3008514029-2023-00143
• Device Sequence Number: 5895893
• Product Code: LGW
• UDI-Device Identifier: 00813426020251
• UDI-Public: 00813426020251
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: 05/09/2022
• Device Model Number: ACCK5300
• Device Catalogue Number: ACCK5300
• Device Lot Number: 5004506
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/18/2023
• Supplement Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female