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

Model Number NIPG1500

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

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned.Nevro had been trying to obtain additional information regarding the details of this case.Nevro is awaiting for the patient's appointment with the physician.

Event Description

It was reported to nevro that a patient had experienced loss of bladder and bowel functions following an implant procedure.The patient stated the symptoms lasted for 4-5 days, and was followed by admission to an er.The patient was prescribed medication to treat the symptoms and is recovering.There have been no further reports of complications.Stimulation is currently on and the patient is under the care of a urologist.

Manufacturer Narrative

Recent follow up confirmed the patient's medical symptoms were not device-related.The patient's issues have been resolved through medication and the patient is under the care of a urologist for an enlarged prostate.

• Brand Name: SENZA
• Type of Device: NEVRO SENZA
• Manufacturer (Section D): NEVRO CORP.; 1800 bridge parkway; redwood city CA 94065
• Manufacturer Contact: rey nossa ; 1800 bridge parkway; redwood city, CA 94065 ; 6504332742
• MDR Report Key: 6728800
• MDR Text Key: 80565803
• Report Number: 3008514029-2017-00190
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00813426020015
• UDI-Public: 00813426020015
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/07/2019
• Device Model Number: NIPG1500
• Device Catalogue Number: NIPG1500
• Device Lot Number: 9439550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2017
• 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: 59 YR