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 Bacterial Infection (1735); Incontinence (1928); Urinary Tract Infection (2120); Urinary Frequency (2275); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

A healthcare provider reported on behalf of a patient that they stopped therapy due to a rash reaction they got after the treatment.Follow up on (b)(6) 2017, from the patient's family member, reported that the patient did not have an allergic reaction to the therapy, but a urinary tract infection.As a result, the patient's symptoms had worsened, going as frequent as 19-20 times a day.They stated that it has been "horrible" and the patient can't go anywhere.It was noted that the healthcare provider was aware of the issue.No further complications are anticipated.

Manufacturer Narrative

Patient code (b)(4) is no longer applicable to the event.

Event Description

Additional information from the healthcare provider stated that the rash the patient has was a bacterial infection secondary to dampness from incontinence.The patient did not have a urinary tract infection, but had incontinence increased and the rash was secondary to it.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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6456561
• MDR Text Key: 71618728
• Report Number: 3007566237-2017-01265
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2017

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: 03/30/2017
• Initial Date FDA Received: 04/04/2017
• Supplement Dates Manufacturer Received: Not provided; 04/04/2017
• Supplement Dates FDA Received: 04/14/2017; 10/02/2017
• 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
• Patient Weight: 90