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

Model Number NIPG2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Retention (2119); Electric Shock (2554)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

The manufacturing records were reviewed and no relevant nonconformities were found.

Event Description

It was reported to nevro that the patient experienced a shocking sensation and urinary incontinence.The device was removed and there have been no reports of further complications regarding this event.

Manufacturer Narrative

The device was returned and analyzed.The device works as expected and successfully completed all the tests performed during the investigation.No abnormality was found that could explain the reported condition.The manufacturing records were reviewed and no relevant nonconformities were found.

Event Description

The device was returned and analyzed.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: catherine aronson ; 1800 bridge parkway; redwood city, CA 94065 ; 6504333218
• MDR Report Key: 11379075
• MDR Text Key: 233509849
• Report Number: 3008514029-2021-00076
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020510
• UDI-Public: 00813426020510
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: NIPG2000
• Device Catalogue Number: NIPG2000
• Device Lot Number: 9444079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 47 YR