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 Fall (1848); Bone Fracture(s) (1870); Weakness (2145); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 01/21/2017

Event Type  Injury  

Event Description

A consumer via a manufacturer representative reported that she fell many times and her mind was very foggy during a period that lasted for almost two weeks, and advised that she could not think well.The falling ceased about four (4) days ago and her mind was functioning again, but she was still feeling weak.The consumer went to her doctor.The issue was noted as not resolved at the time of the report.A patient reported they had been falling and that they fell and broke their arm.No further complications are anticipated.

Event Description

Additional information reported that on 2017-01-16 the patient¿s healthcare provider received notice that the patient was having an adverse reaction to toviaz.No reports of any other falls until (b)(6) 2017.The patient was taken to the emergency room on either (b)(6) 2017 due to severe tremors, no cognitive responses and inability to walk/stand.The patient was told to discontinue their medications by their healthcare provider.The cause of the patient¿s fall and breaking their arm was unknown.

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6486779
• MDR Text Key: 72589074
• Report Number: 3007566237-2017-01386
• 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,Followup
• Report Date: 04/21/2017

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: 03/20/2017
• Initial Date FDA Received: 04/12/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/17/2017
• Supplement Dates FDA Received: 04/21/2017; 04/21/2017; 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
• Patient Weight: 70