MAUDE Adverse Event Report: MEDTRONIC MINIMED MINIMED INSULIN PUMP; PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Memory Loss/Impairment (1958); Brain Injury (2219); Coma (2417)

Event Date 10/23/2020

Event Type  Injury  

Event Description

Coma while driving, injured, self broken bones and son had broken bones.Both hospitalized for major surgeries; i also had traumatic brain injury, lost my short term memory.Fda safety report id# (b)(4).

• Brand Name: MINIMED INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 12711991
• MDR Text Key: 278801327
• Report Number: MW5105008
• Device Sequence Number: 1
• Product Code: OYC
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: BACLOFEN AND OTHERS; DIET PILLS; INSULIN PUMP; PERCOCET; SPORE
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 50 YR
• Patient Weight: 82