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 Urinary Tract Infection (2120); No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2016

Event Type  Injury  

Event Description

The consumer reported that the patient was on session week 4.In 2016, the patient had been fighting a bladder infection or urinary tract infection (uti) through most of their peripheral tibial neuromodulation (ptnm) journey.The health care provider (hcp) gave the patient antibiotics and then 3 shots after the infection did not respond to the antibiotic.The patient felt as though it may be coming back.The patient periodically had utis and their internist had them on an antibiotic to try to keep it from coming back, but all of the sudden it came back quite strongly.The hcp was aware and the patient was going to their hcp's office on (b)(6) 2016 to check up on this.The event was ongoing.

Manufacturer Narrative

Patient code (b)(4) no longer applies to the event.

Event Description

Additional information received from the consumer reported they were on session week 11.The patient had 4 urinary/bladder infections since starting the peripheral tibial neuromodulation (ptnm) therapy.The patient recently had their fourth infection, but it has cleared up now.The cause of the bladder infection/utis was not determined.The utis were not related to the patient¿s underlying urinary dysfunction and were not related to their device or therapy.The actions performed for the utis were antibiotic therapy.

• 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: 5977470
• MDR Text Key: 55613082
• Report Number: 3012165443-2016-00016
• 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: 12/02/2016

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: 09/07/2016
• Initial Date FDA Received: 09/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2016
• 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