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 Rheumatoid Arthritis (1724); Urinary Retention (2119); Therapeutic Response, Decreased (2271)

Event Date 11/04/2016

Event Type  Injury  

Event Description

A trial patient reported that her rheumatoid has been flaring up.She was not able to attend her session last week and was advised that her symptom improvement has gone backwards over the last two weeks.The patient spoke to healthcare provider (hcp) a day prior to this report and they did a scan of her bladder which showed that the patient still had fluid inside of her bladder.It was indicated that patient has another consult with the hcp on (b)(6) 2016.The patient was advised that she may have to consider another type of therapy since they found fluid inside of her bladder.It was noted that patient had 12 sessions completed on (b)(6) 2016.The event outcome was noted as ongoing.

• 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 1200
• Manufacturer (Section G): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6169626
• MDR Text Key: 62238815
• Report Number: 3007566237-2016-04367
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

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: 12/13/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/13/2016
• 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