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 Unspecified Infection (1930); Urinary Retention (2119)

Event Date 02/10/2017

Event Type  Injury  

Event Description

The patient reported that they tend to get bladder infections and has one small infection since the beginning of their ptnm treatments but has been resolved.It was unknown if any environmental/external/patient factors led or contributed to the issue.The patient stated that they had colon cancer years ago and was advised that they would have bladder issues down the road.The patient had severe bladder issues and would catheterize about 15 times a day and retains urine.The number of times they catheterizes per day has not changed since beginning the ptnm treatments.The patient began their ptnm treatments on (b)(6) 2017.The patient was reported to be alive with no injury.No further complications were reported/anticipated.

Event Description

Additional information from the patient reported their symptoms are much better and they had a good flow, but still catheterizing after.No further complications were reported/anticipated.

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): 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: 6515878
• MDR Text Key: 73493849
• Report Number: 3007566237-2017-01548
• 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: 05/26/2017

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: 03/27/2017
• Initial Date FDA Received: 04/24/2017
• Supplement Dates Manufacturer Received: Not provided; 05/01/2017
• Supplement Dates FDA Received: 05/26/2017; 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): Other