MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION 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 Incontinence (1928); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 06/01/2017

Event Type  Injury  

Event Description

A patient reported that their symptoms were "about the same each time".They later stated that the symptoms improved a little bit, but not much.Additional information received from the patient indicated that they could not tell if they were really any better.They advised that some days the therapy was working okay, but not as much lately.The patient stated that they leak a lot, and the leaking started a few months ago, after they had started percutananeous tibial neuromodulation (ptnm) therapy.They mentioned that the healthcare provider (hcp) had done botox on the patient previously, and it was painful.The patient stated that nothing seemed to work on them for anything.It was noted that the patient was trying a new regimen for their colon because they had scar tissue from previous surgeries.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: 6917579
• MDR Text Key: 88387980
• Report Number: 3007566237-2017-04199
• 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
• Report Date: 10/05/2017

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: 09/07/2017
• Initial Date FDA Received: 10/05/2017
• 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: 78 YR