MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC STRATA II

Device Problems Use of Incorrect Control/Treatment Settings (1126); Electromagnetic Interference (1194); Occlusion Within Device (1423)

Patient Problem Cognitive Changes (2551)

Event Date 07/02/2015

Event Type  Injury  

Event Description

Medtronic strata ii valve does not hold it settings.Magnetic fields in our home changed the setting from 0.5 (lowest) to 2.5 (highest).My husband did not leave the home hardly at all so we are attempting to figure out what caused the change.Many mental changes, behavioral changes, and physical changes which are attributed to the higher setting.This has happened one other time with the medtronic shunt, along with a complete blockage of the catheter end in the brain.Is this a faulty product?.

• Brand Name: MEDTRONIC STRATA II
• Type of Device: MEDTRONIC STRATA II
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4905715
• MDR Text Key: 6534975
• Report Number: MW5043914
• 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: 07/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Patient Sequence Number: 1
• Treatment: PACEMAKER; TRAZODONE; CLONAZEPAM; WELLBUTRIN; PROZAC
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 91