MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. NURO EXTERNAL NEUROSTIMULATOR; STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION

Model Number 3533

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Urinary Retention (2119); Sleep Dysfunction (2517)

Event Date 09/09/2016

Event Type  Injury  

Event Description

The consumer reported that the patient had their 7th peripheral tibial neuromodulation (ptnm) treatment on (b)(6) 2016.Every week after the patient got the treatment, they had a different symptom in 2016.Last week or 2 weeks ago, the patient felt like they had to go to the bathroom and went to sit down, but could not urinate and could not release the urine.Fifteen minutes later , the patient wet their pants and could not get back to the toilet fast enough.One week the patient started to leak as they walked out of their health care provider's (hcp's) office after their treatment.The patient had not leaked for a long time.Another week, all of the sudden the patient started waking up every morning at 4 a.M.To go to the bathroom.That lasted for 2 weeks.It had not happened for the last couple of nights.It was weird, but was better than wetting the bed.The patient slept on a pad.The symptoms did not last long, maybe a couple of weeks, like a week or 2 for the most.Today the patient told the nurse about the symptoms and they were going to tell the hcp.

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

Additional information received from the consumer reported that the patient had followed-up with their health care provider (hcp) regarding their symptoms and they were not concerned about the symptoms.Before the patient started therapy they would just wet themself and not really know it.Now the patient was actually improving considering where they started.The patient did not have any pain and planned to continue with the therapy.The patient was not up every night at 4 a.M., just occasionally.The patient's incontinence was improved since they started.The patient was not concerned.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: NURO EXTERNAL NEUROSTIMULATOR
• 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: 6100073
• MDR Text Key: 59788994
• Report Number: 3012165443-2016-00021
• 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,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 11/15/2016
• 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): Other