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 Unspecified Infection (1930); Muscle Spasm(s) (1966)

Event Date 12/23/2016

Event Type  Injury  

Event Description

A patient reported that they experienced two urinary tract infections (uti) while undergoing the external neurostimulator (ens) percutaneous tibial neurostimulation treatments.They could not recall when they had the first one, however, the second uti was around (b)(6) 2016.The patient noted that they get uti's quite often, including prior to starting the ptnm treatments.It was further noted that the patient was placed on antibiotics and had since returned to the healthcare providers office on (b)(6) 2017, where they did a urine test and advised the patient that it came back clear of any infection.During the report, there were no symptoms and the issue was noted as resolved.

Event Description

Additional information reported that the patient experienced a 3rd bladder infection.The patient was having spasms and went into the urologist on (b)(6) 2017 where they took a sample and the infection was confirmed.It was unknown if any environmental/ external/patient factors that may have led or contributed to the issue.The patient was placed on antibiotics.It was also noted that the patient¿s issue was not resolved at the time of the report.The patient was also reported to be alive with no injury.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6253633
• MDR Text Key: 64882921
• Report Number: 3012165443-2017-00002
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2017

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: 01/09/2017
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/06/2017
• 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