MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NURO; STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION

Model Number 3533

Device Problems Failure to Deliver Energy (1211); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Incontinence (1928); Pain (1994); Therapeutic Effects, Unexpected (2099); Urinary Tract Infection (2120); Tingling (2171); Therapeutic Response, Decreased (2271)

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 patient reported that they had pulled muscles and were on medication that set their symptom relief back with the percutaneous tibial neuromodulation (ptnm) therapy.They indicated that they didn't have the control they had before they started taking the muscle relaxants and pain pills for their pulled muscles.The patient stated that a week following this, they found out they had a urine infection, and were placed on medication for three days.It was noted that they did not have symptoms, only lower back pain.They thought this was because the muscle spasms weren't getting better.The healthcare provider (hcp) decided to take a urine sample, and it was determined that the patient had a urine infection.This was the first that the patient had ever had.It was indicated that they were waiting to see if they still had one.They didn't think so because their urgency had been better in the last couple of weeks.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.

Manufacturer Narrative

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 completed 14 sessions.The patient later provided contradicting information that they went through 14 sessions, and then had two extra ones.They stated that they had started the therapy at the end of (b)(6) 2017, and it was effective and perfect.All symptoms were nearly gone.It was indicated that it was going so well the first few weeks until they hurt/pulled their back a couple months into it.They didn't have any falls or trauma, they had a bad back and "sometimes it happens." they mentioned that the sessions didn't help starting in (b)(6) 2017.They were back to square 1, and were as bad as prior to starting the therapy.They didn't know if the therapy no longer working was due to them hurting their back, the medication they were on, or them getting a urinary infection in (b)(6)2017.It was noted that the patient was on oral medication for the infection for three days, which took care of it.The patient also reported that they never felt stimulation in their bicycle seat area, but when they would turn up the "signal" to the point where their foot would tingle, sometimes it wouldn't, and sometimes it hurt on the insertion site.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): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6897719
• MDR Text Key: 87513043
• Report Number: 3007566237-2017-04083
• 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
• Report Date: 11/16/2017

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: 09/01/2017
• Initial Date FDA Received: 09/27/2017
• Supplement Dates Manufacturer Received: 10/13/2017; 11/16/2017
• Supplement Dates FDA Received: 11/02/2017; 11/16/2017
• 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): Required Intervention
• Patient Age: 71 YR