MAUDE Adverse Event Report: MEDTRONIC ACTIVA DBS

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

Patient Problems Death (1802); Loss of consciousness (2418); Low Oxygen Saturation (2477); Respiratory Failure (2484)

Event Type  Death  

Event Description

Summary: patient death due to chronic respiratory failure that developed as a complication to his need for pain management and antispasmodics.He was unable to wean from mechanical ventilation.Patient had suicidal behavior with attempted self-injury and psychiatry intervention.Dnr was signed after extensive family conference.Course: on (b)(6) 2017 patient was hospitalized for ventilator weaning.This was accomplished without complication and with normal pco2's and tolerance of room air.Subsequent to this, patient became increasingly combative and had repeated tracheostomy decannulation episodes.On (b)(6) 2017, the patient again self decannulated.He was stable without stridor or oxygen requirement.Tracheostomy cannula could not be reinserted by the med alert team.A family conference was held with treating physicians, representatives from nursing and hospice administration, and the family.The decision was made not to replace the tracheostomy surgically, and to institute a dnr order.On (b)(6) 2017, the patient suddenly became unresponsive, in the late afternoon.He never again regained consciousness.He had gradual decrease in oxygen saturation, and increased intolerance of feedings over the night of (b)(6) 2017.On (b)(6) 2017 at 1:10 pm he was pronounced dead.

• Brand Name: ACTIVA DBS
• Type of Device: ACTIVA DBS
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6587462
• MDR Text Key: 75851055
• Report Number: MW5070007
• Device Sequence Number: 1
• Product Code: MRU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: G-BUTTON 18-FRENCH 2.5; MICKEY - EPIDURAL CATHETER; TRACHEOSTOMY
• Patient Outcome(s): Death
• Patient Age: 18 YR
• Patient Weight: 75