MAUDE Adverse Event Report: NEVRO CORP SENZA; NEVRO SENZA

Model Number	ACCK1015
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow up report indicated that the patient had recovered from the surgery.There is no report of impact or consequence to the patient.Nevro is awaiting the return of the device for analysis.
Event or Problem Description
It was reported to nevro that the insertion needle detached from the hub during a permanent procedure.The detached needle was retrieved with no harm to the patient and the case was completed successfully.
Additional Manufacturer Narrative
The needle hub was returned detached from the cannula.There were no defects found on the surface of the cannula body.High magnification was used to observe fracture surfaces.The inspection revealed insufficient solder material at the hub and cannula circumference.This issue has been addressed with the manufacturer and corrective action has been implemented.Review of the severity and occurrence rate for this type of event shows that the overall risk is within acceptable limits.

• Brand Name: SENZA
• Common Device Name: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP; 1800 bridge parkway; redwood city CA 94065
• MDR Report Key: 6205847
• Report Number: 3008514029-2016-00133
• Device Sequence Number: 13635795
• Product Code: LGW
• UDI-Device Identifier: 00813426020183
• UDI-Public: 00813426020183
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2017

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: Physician
• Device Expiration Date: 10/09/2018
• Device Model Number: ACCK1015
• Device Lot Number: 9436289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2016
• Supplement Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR