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 Micturition Urgency (1871); Hemorrhage/Bleeding (1888); Therapeutic Effects, Unexpected (2099); Urinary Retention (2119); Complaint, Ill-Defined (2331)

Event Date 06/24/2016

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 via a manufacturer representative reported that the patient was on therapy session 9 on (b)(6) 2016.Whenever the patient had a session, they had the urge to urinate afterwards and only trickles and a small amount came out.Then the patient had another urge to urinate after a little while where they released the urine.The patient had urgency and was unable to empty their bladder and the event was ongoing.

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 via a manufacturer representative reported that the patient had urgency symptoms with just a trickle of urine 3 to 4 times experienced after their peripheral tibial neuromodulation (ptnm) treatments.It occurred for a couple of days then resumed back to normal.The patient wondered if it was the treatment causing this or due to a disruption of weekly treatment as they had to skip 2 weeks.The patient hadn't experienced this prior to treatment.The patient had finished their 12th week of ptnm treatment and their symptoms persisted.

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 health care provider (hcp) via a manufacturer representative reported that the patient had unusual symptoms after peripheral tibial neuromodulation (ptnm) therapy.The patient's urgent symptoms were not relieved until close to the next monthly appointment time, their leg felt like wood, and they had some vaginal spotting.

Manufacturer Narrative

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

• 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: 5793828
• MDR Text Key: 49514341
• Report Number: 3012165443-2016-00009
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/22/2016

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: 06/24/2016
• Initial Date FDA Received: 07/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 08/30/2016
• Supplement Dates FDA Received: 07/25/2016; 07/25/2016; 09/22/2016; 09/24/2017
• 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): Other