MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. NURO; STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION

Model Number 3533

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

Patient Problem Urinary Tract Infection (2120)

Event Date 04/10/2017

Event Type  Injury  

Event Description

A patient reported they had a urinary tract infection (uti) since the week prior to the report.The patient was on phase 3 session 5.No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NURO
• Type of Device: STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
• Manufacturer (Section D): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer (Section G): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6513246
• MDR Text Key: 73448187
• Report Number: 3012165443-2017-00014
• Device Sequence Number: 1
• Product Code: NAM
• Combination Product (y/n): N
• PMA/PMN Number: K132561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2017

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
• Device Operator: Health Professional
• Device Model Number: 3533
• Device Catalogue Number: 3533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/18/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: 04/18/2017
• Supplement Dates FDA Received: 10/03/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other