MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY META STRATA VP SHUNT; SHUNT CENTRAL NERVOUS SYSTEM AND COMPONENTS

Device Problems Self-Activation or Keying (1557); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Code Available (3191)

Event Date 11/14/2016

Event Type  Injury  

Event Description

In (b)(6) of 2016 my husband went for his 4 month check up of his strata adjustable vp shunt after leaving acute therapy.He had an mri before the check up with his neurosurgeon who placed the shunt.I recalled four months later during another routine check up with an mri which showed that my husbands ventricles had increased in size by 0.5mm.This finding leads the neurosurgeon to check the setting of the shunt and observed that it was adjusted from 1.5 to 0.5, he is adjusted back to 1.5 once he checked it, but i didn't recall the neurosurgeon checking the setting during the (b)(6) 2016 visit after the mri.I also wasn't informed by his neurosurgeon that the vp shunt could be impacted by magnetic forces.

• Brand Name: META STRATA VP SHUNT
• Type of Device: SHUNT CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY
• MDR Report Key: 6696601
• MDR Text Key: 79631902
• Report Number: MW5070854
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• 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: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 95