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 Problems Incontinence (1928); Pain (1994); Urinary Tract Infection (2120); Malaise (2359)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A patient reported that the last ptnm therapy session they had on (b)(6) 2017 really affected them.The patient stated that they did not realize that they had a bladder infection.After they had their last session "down really low" started hurting and it hurt through the weekend.They went to the healthcare provider (hcp) and they had a urinary tract infection (uti).They were unsure if the treatment had anything to do with it.The patient said it still kind of hurts when they bend over and they were "pouring a lot", and "having to change pads really often." they stated they had "been really kind of sick this week." the patient stated they were happy thinking that it would help, but the last week made them unsure.They were so worried about their bladder because their grandmother had bladder cancer, so they may have to do more testing if it continues.The patient further reported that the hcp gave them a prescription and when they finish it they will be taking something every day.They thought that they would continue on once a month, but they did not know.They were still taking meds and their symptoms were not better by the time they finished the meds, they would go back to see the hcp.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: 6544349
• MDR Text Key: 74418710
• Report Number: 3012165443-2017-00018
• 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: 05/04/2017

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: 05/02/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: 05/02/2017
• 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): Required Intervention