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 Chest Pain (1776); Dehydration (1807); Low Blood Pressure/ Hypotension (1914); Swelling (2091); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

A patient reported they missed their 8th ptnm session on (b)(6) 2017 because they were in the hospital.They had pains in the chest and their blood pressure was low and they were having chest spasms.They went to see a cardiologist the day prior to the report for heart spasms and they were unsure of what was causing it.They were not feeling any better on the day of the report, and they could not walk.Their left leg was so swollen.The healthcare provider (hcp) was aware of the issue, but they were not sure what they were going to do.The patient stated that the hcp's said they were dehydrated because they were not drinking enough.The patient noted they had gout and they were on medication for it.They were also taking medication for urinary symptoms.The patient began their ptnm therapy sessions on (b)(6) 2017.No further complications were reported/anticipated.

Manufacturer Narrative

Product problem is no longer applicable to this event.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a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.

Manufacturer Narrative

It was initially reported that the patient had 1 ptnm session.This information was incorrect.

Event Description

The patient had completed 11 percutaneous tibial neuromodulation sessions.

Manufacturer Narrative

After review, patient codes (b)(4) no longer apply to this event.Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.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.

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 patient indicated that they had been in and out of the hospital.They were having problems with their heart, and were on two different types of medications.Their perception of therapy was a 5 due to having ten hernia operations on their right side as well as a testicle removed.The patient further provided that they had "a problem." the patient had completed 1 percutaneous tibial neuromodulation sessions.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.

• 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 30188
• Manufacturer (Section G): ADVANCED URO-SOLUTIONS, L.L.C.; 7842 hickory flat highway; suite d; woodstock GA 30188
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6539186
• MDR Text Key: 74252259
• Report Number: 3012165443-2017-00017
• 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,Followup,Followup,Followup
• Report Date: 06/27/2017

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?: 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
• Initial Date Manufacturer Received: 04/28/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; 06/12/2017
• Supplement Dates FDA Received: 05/12/2017; 06/07/2017; 06/07/2017; 06/27/2017; 10/03/2017
• 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): Hospitalization
• Patient Age: 80 YR