MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. NURO EXTERNAL NEUROSTIMULATOR; 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 Bacterial Infection (1735); Hemorrhage/Bleeding (1888); Urinary Retention (2119); Urinary Tract Infection (2120); Numbness (2415)

Event Date 07/31/2016

Event Type  Injury  

Event Description

The consumer reported that years ago the health care provider (hcp) took a piece of the patient's upper right leg and did a fascial sling because they had urgency, their bladder did not empty, and if the patient got an infection it stayed in the bottom of the bladder.Two weeks ago in (b)(6) 2016, the patient had their fourth treatment and they wanted a specimen.The patient couldn't go, but they catheterized them and got a whole cup out and cultured it and found bad bacteria.The patient had a bacterial infection.The patient had their fifth session on (b)(6) 2016 and the needle site was bleeding.The patient never had any problems before and had numbness on their toes and bottom of feet since the morning of (b)(6) 2016.The patient woke up fine on (b)(6) 2016.The hcp's office told the patient to call the manufacturer to know what the side effects of the device were.The patient would have an appointment with their hcp on (b)(6) 2016.

Event Description

Additional information received from the health care provider (hcp) reported that the patient had a urinary tract infection (uti) and no urinary retention.There was no device issue, patient issue, or procedure issue.The action taken to resolve the infection was that the patient was treated with antibiotics for 7 days.The cause of the infection was not determined.The issue had been resolved.

Manufacturer Narrative

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

• Brand Name: NURO EXTERNAL NEUROSTIMULATOR
• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5935654
• MDR Text Key: 54167603
• Report Number: 3012165443-2016-00013
• Device Sequence Number: 1
• Product Code: NAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2016

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: 08/18/2016
• Initial Date FDA Received: 09/08/2016
• Supplement Dates Manufacturer Received: Not provided; 10/18/2016
• Supplement Dates FDA Received: 10/20/2016; 09/25/2017
• 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