MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY MEDTRONIC STRATA II BRAIN SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problems Infusion or Flow Problem (2964); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Intracranial Hemorrhage (1891); Convulsion/Seizure (4406)

Event Date 12/27/2020

Event Type  Death  

Event Description

(b)(6) (my father) began having behavior that prompted me to be concerned about shunt failure on (b)(6) 2020.We do not know exactly how long the problem had existed but once dad was hospitalized in the evening we were told the shunt had not failed in the traditional sense (no blockage).However, what was discovered was that the setting had "spontaneously" changed from a 1.0 to a.5.Dad had been isolated during covid-19 and we could not figure out what might have caused a shunt setting change other than a defect or device failure.This resulted in a 'brain bleed' (bilateral so i suspect it may have been like that awhile).The shunt spontaneously over drained my father's brain fluid.He was having seizures within 12 hours of being at the hospital.They adjusted his shunt to 2.0 to allow fluid to rebuild.He never made it home.Went unresponsive in the hospital and died on (b)(6) 2021.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC STRATA II BRAIN SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 11824778
• MDR Text Key: 250823000
• Report Number: MW5101335
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR