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 Urinary Tract Infection (2120); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

A patient reported that their urinary incontinence was worse than before.They also stated that they fell on (b)(6) 2017 and had been having knee swelling since.The patient mentioned they saw their healthcare provider on (b)(6) 2017 and they advised the patient to use ice to reduce the swelling.The ptnm therapy sessions began on (b)(6) 2017.It was noted that the patient has a past medical history of rheumatoid arthritis.Follow up from the healthcare provider, on (b)(6) 2017, noted that the patient had a urinary tract infection at the start of treatment and they were treated for the uti on (b)(6) 2017.The hcp noted that per the staff at the patient's home, they patient has a history of knee/joint pain.They were unaware of the symptoms worsening and the patient falling.No further complications are anticipated.

Event Description

Additional information from the healthcare provider reported that the cause of the urinary tract infection was unknown.They stated that they could not say that the ptnm device or therapy caused the uti, worsened symptoms or fall.The staff at the patient's home facility stated that the patient had multiple falls and leg pain prior to the ptnm therapy.The patient does have assistance from home care staff with transfers when they come to their visits.No further complications were reported/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

Analysis of the nuro device (b)(4) found no anomalies.The device passed all functional testing.If information is provided in the future, a supplemental report will be issued.

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 MN 30188 1200
• Manufacturer (Section G): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock,ga MN 30188 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6453611
• MDR Text Key: 71529235
• Report Number: 3007566237-2017-01242
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2018

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/20/2017
• Initial Date FDA Received: 04/03/2017
• Supplement Dates Manufacturer Received: Not provided; 04/12/2017; 07/11/2018; 08/08/2018
• Supplement Dates FDA Received: 04/17/2017; 10/17/2017; 08/07/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• 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
• Patient Weight: 116