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 Bacterial Infection (1735); Diarrhea (1811); Incontinence (1928); Therapeutic Response, Decreased (2271); Urinary Frequency (2275); Complaint, Ill-Defined (2331)

Event Date 07/01/2016

Event Type  Injury  

Manufacturer Narrative

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

The consumer reported that the patient completed their 12 sessions on (b)(6) 2016 and now that they had completed all 12 sessions, their symptoms had reversed in (b)(6) 2016.The therapy was doing off on and on, and it was doing well.Then everything changed and the patient's "kidneys explode all the time and it was like a water faucet." normally after a session the patient would be constantly urinating and would go through 12 diapers a night and then a couple of days later they would be normal for a while.The patient was currently taking medication for e-coli.The patient's health care provider (hcp) was aware and they may be going forward with botox treatments after they finished taking the medication for e-coli.The patient had urinary incontinence and explosive diarrhea from all the medications they were on.The patient would have an ultrasound for their kidneys on (b)(6) 2016 and then had to go back to the urologist.The patient did not want to do any more peripheral tibial neuromodulation (ptnm) sessions.Sacral neuromodulation (snm) was mentioned twice on 2 separate occasions and it was dependent on a lot of things and the patient would discuss with their hcp.However, the next course of action would be botox if everything went well.The event was 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
• 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: 5876001
• MDR Text Key: 52099001
• Report Number: 3012165443-2016-00012
• 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
• Report Date: 08/15/2016

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: 07/25/2016
• Initial Date FDA Received: 08/15/2016
• 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