MAUDE Adverse Event Report: ADVANCED URO-SOLUTIONS, L.L.C. NURO; 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 Unspecified Infection (1930); Therapeutic Effects, Unexpected (2099); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

The patient reported that there were times that they felt like they were ready to burst, would get to the bathroom, stand there for 5-10 minutes, and maybe a little urine would come out.There were other times when the urge would hit, and they would barely make it to the bathroom.These symptoms began prior to the percutaneous tibial neuromodulation (ptnm) treatments.It was indicated that the primary symptom they were being treated for was the process of urinating.The patient noted that they urinated a quart.The issue was not resolved.It was further provided that the patient had leaking prior to the ptnm treatments, but not since.Their healthcare provider (hcp) told them that they had an obstruction, so the hcp clipped it out, and widened the tube running off their bladder.The patient had completed two ptnm sessions at the time of report.There were no further complications reported as a result of this event.Additional information reported that the patient couldn't really tell if the treatment improved their urinary problems.The patient stated that they were a new man for a couple of weeks however they had an infection prior to starting the ptnm sessions and now seemed to be having the same symptoms.It was unknown if the infection had been resolved.The patient reported that their healthcare provider sent their tests off to be biopsied to check the pathology.It was unknown if any environmental/external/patient factors that may have led or contributed to the issue.The patient was reported to be alive with no injury.No further complications were reported/anticipated.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the healthcare provider (hcp) indicated that the cause of the urinary obstruction was due to the urethral structure that was long standing and had been there for a long time.The patient was treated on (b)(6) 2017.There were no further complications reported as a result of this event.

Manufacturer Narrative

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

Event Description

The patient reported that they were in and out of the hospital so they have not been able to go to their the ptnm sessions.The patient had 3 stints put in because they had a blockage in their heart.The patient noted that they were satisfied with the treatment.The patient noticed the last time they were there that they felt it a little more in their calf than they had the time before.The patient also had a tens machine that they use on their back because their back gives them some trouble.It was unknown if any environmental/external/patient factors that may have led or contributed to the issue.The patient has completed 4 or 5 ptnm sessions.There were no further complications reported as a result of this event.

• Brand Name: NURO
• 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 MN 30188 1200
• Manufacturer (Section G): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock,ga MN 30188 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6710199
• MDR Text Key: 79917415
• Report Number: 3007566237-2017-02841
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2017

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: 06/16/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 07/17/2017; 08/08/2017
• Supplement Dates FDA Received: 08/01/2017; 08/31/2017
• Date Device Manufactured: 04/01/2016
• 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
• Patient Weight: 106