MAUDE Adverse Event Report: ST. JUDE AMPLATZER

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

Patient Problem Headache (1880)

Event Date 07/15/2015

Event Type  Injury  

Event Description

New onset chronic migraine with aura after installation of amplatzer device.

• Brand Name: AMPLATZER
• Type of Device: AMPLATZER
• Manufacturer (Section D): ST. JUDE
• MDR Report Key: 6438734
• MDR Text Key: 71164190
• Report Number: MW5068677
• Device Sequence Number: 1
• Product Code: MLV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: ASPIRIN; MAGNESIUM; OTC MEDS: VITAMIN B; RX MEDS: PROPANOLOL TO CONTROL MIGRAINES
• Patient Outcome(s): Disability
• Patient Age: 12 YR
• Patient Weight: 48