MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. NURO EXTERNAL STIMULATOR; 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); Urinary Tract Infection (2120); Therapeutic Response, Decreased (2271)

Event Date 08/03/2016

Event Type  Injury  

Event Description

The consumer reported that the patient was on session week 10.There was an ongoing problem that started 3 weeks ago on (b)(6) 2016 with the patient having a urinary tract infection (uti) or an infection.The patient had ongoing symptoms of a uti.The hcp was working on treating the uti with the patient.The patient's spouse believed that next week the patient would be in for another session, after which they would see a hcp from the infectious disease urology department.The patient had a history of utis, but it usually occurred every 6 months.This uti had lasted for a period of 3 to 4 weeks.

Manufacturer Narrative

Outcome attributed to adverse event other no longer applies to the event.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

Additional information received from the consumer reported that the patient completed their 12 sessions on (b)(6) 2016.The patient had a uti since (b)(6) 2016.The patient was also receiving symptoms relief from the peripheral tibial neuromodulation (ptnm) therapy until about the 5th or 6th session when they got the uti.The patient had ongoing symptoms of a uti and urinary incontinence.The patient¿s health care provider (hcp) was aware the patient was currently on their 5th course of antibiotics.After this course of antibiotics, the hcp would test the bacteria to see if it was still immune.The urologist had suggested sacral neuromodulation (snm) therapy and advised the patient to think about it.The patient¿s spouse thought that the uti caused the therapy not to work.

• Brand Name: NURO EXTERNAL STIMULATOR
• 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: 5969857
• MDR Text Key: 55363762
• Report Number: 3012165443-2016-00015
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2016

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: 08/30/2016
• Initial Date FDA Received: 09/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2016
• 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): Other; Required Intervention