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); Inflammation (1932); Urinary Frequency (2275); Discomfort (2330); Malaise (2359)

Event Date 10/26/2016

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 reported that the patient had completed 2 sessions so far.After the patient¿s second session on (b)(6) 2016 by the middle of the next day they weren¿t feeling good.The patient was up all night going to the bathroom and by morning had a lot of pressure in their bladder.The patient went into the walk-in clinic and they thought it could have been their diverticulitis, but the patient felt it was so completely different from what they were used to.This started a different way because normally the patient would experience pressure on the left side, but this time they felt it on the right side.The patient had a ct scan and the health care provider (hcp) said it was acute diverticulitis.The patient didn¿t know whether it was the peripheral tibial neuromodulation (ptnm) therapy or their diverticulitis, but they were leery about doing anymore of the ptnm sessions.The hcp recommended the patient see a specialist to look at that part of the colon.The patient saw the surgeon and was advised they would have to have many attacks before considering surgery.The patient was currently on antibiotics and felt a bit better.The patient would have a consult with their hcp on (b)(6) 2016.

Manufacturer Narrative

(b)(4).

Event Description

Additional information from the healthcare provider (hcp) determined that the patient's diverticulitis and administration of antibiotics were not related to the device or therapy.

• Brand Name: NURO
• Type of Device: STIMULATOR,PERIPHERAL NERVE,NON-IMPLANTED,FOR PELVIC FLOOR DYSFUNCTION
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; suite d; minneapolis,mn GA 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; suite d; minneapolis,mn GA 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6165532
• MDR Text Key: 62118822
• Report Number: 3012165443-2016-00023
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2017

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: 11/14/2016
• Initial Date FDA Received: 12/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/05/2017
• 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