MAUDE Adverse Event Report: AMPLATZER; TRANSCATHETER SEPTAL OCCLUDER

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

Patient Problems Dyspnea (1816); Headache (1880); Pain (1994); Weakness (2145); Dizziness (2194); Numbness (2415); Neck Pain (2433)

Event Date 07/08/2019

Event Type  Injury  

Event Description

Experienced severe ear pressure, felt like eardrums would explode, severe neck pain, arm pain and numbness and leg pain and numbness for extended period of time.Could barely walk unassisted.Extremely dizzy.Felt short of breath but o2 stat 100%.Stayed at dr's office for extended period.Cardiac specialist called in to read tests, said initial read looks good.No echo results yet.Administered caffeine to flush lexiscan (sp).First told normal reaction but normally not as severe and usually only lasts a couple of mins.Clearly you're not feeling well but don't believe it's the medicine, except fine until meds were administered.Questioned if allergic reaction.Questioned if she was having a heart attack or did med trigger a stroke.Told no, bp was somewhat elevated but told in range expected to see.Told to go to er if felt like needed to be checked out or if symptoms did not subside or returned.Headache and pressure in head and ears continued through evening but nowhere near as severe.I had tia a number of years ago (10 prox) and occluder put in."have medical card with info if n".Fda safety report id # (b)(4).

• Brand Name: AMPLATZER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• MDR Report Key: 8795131
• MDR Text Key: 151588586
• Report Number: MW5088183
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): Y
• 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: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 61