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

Model Number	LEAD1058-90B
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing records were reviewed and no issues related to the nature of the complaint were found.The device was not available for return.
Event or Problem Description
It was reported to nevro that the most distal electrode on the lead broke off in the patient during the implant procedure.The patient did not sustain any injuries.The electrode was left in the subcutaneous tissue and the physician did not note any concerns or plans to remove the electrode.The procedure completed without further complications and the patient is currently using their device 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
• MDR Report Key: 9446029
• Report Number: 3008514029-2019-00526
• Device Sequence Number: 19552567
• Product Code: LGW
• UDI-Device Identifier: 00813426020053
• UDI-Public: 00813426020053
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P130022
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/29/2021
• Device Model Number: LEAD1058-90B
• Device Catalogue Number: LEAD1058-90B
• Device Lot Number: 94431292
• 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: 11/18/2019
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR