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 Asthma (1726); Bronchitis (1752); Incontinence (1928); Unspecified Infection (1930); Irritation (1941); Muscle Spasm(s) (1966); Pain (1994); Respiratory Distress (2045); Thrombosis (2100); Complaint, Ill-Defined (2331)

Event Date 03/15/2017

Event Type  Injury  

Event Description

A patient reported that the first four sessions of their ptnm therapy sessions were good and then the 5th one was terrible.They had to discontinue the treatments.During the fifth treatment, they had a lot of pain during and after the "injection".The bottom on their foot hurt since then for at least two weeks.They had severe pain and spasms up their legs and still has spasms once or twice a day on their upper leg.They get up in the morning and have a lot of pain in their leg, and then again before they go to bed at night.They have pain.Their last ptnm treatment was on (b)(6) 2017 and that following monday they went into the er for bronchitis/asthma attack.They could not breathe and they were coughing all the time.They were placed on oxygen.The following friday, they went into the hospital and was there until about a week ago.An ultrasound showed some blood clot areas, but nothing to pinpoint the problem.They stated that their bladder was terrible again and they had no control.The patient stated they had been on many antibiotics and they were not sure if that helped, but they were feeling better.They were doing physical therapy, still wearing 5 pads per night and when they wake up in the morning the pad is soaked.The patient would follow up with their hcp.No further complications are anticipated.

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.

• 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: 6504575
• MDR Text Key: 73221388
• Report Number: 3007566237-2017-01488
• 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
• Report Date: 04/19/2017

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: 04/06/2017
• Initial Date FDA Received: 04/19/2017
• Supplement Dates Manufacturer Received: 04/06/2017
• Supplement Dates FDA Received: 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