MAUDE Adverse Event Report: AGA AMPLATZER

Model Number 9-ASD-MD-025

Device Problem Nonstandard Device (1420)

Patient Problems Pain (1994); No Code Available (3191)

Event Date 05/07/2007

Event Type  Injury  

Event Description

Had an amplatzer multi-fenestrated septal occluder cribiform device implanted in 2007, actually awoke with horrific pain in groin during it.Received the id card a year later but the doctors name on the id card is not the doctor who performed this closure.The product number matches the exact recall # 9-asd-mf-025, how can this be? there are 2 or more device w/the exact identical number.Please advise i am beyond frustration and am truly convinced this device has literally destroyed my life.I have all the dictation and none of them match the identification card.Please advise asap.

• Brand Name: AMPLATZER
• Type of Device: AMPLATZER
• Manufacturer (Section D): AGA
• MDR Report Key: 4253519
• MDR Text Key: 5011703
• Report Number: MW5039052
• 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: 11/07/2014

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: Health Professional
• Device Model Number: 9-ASD-MD-025
• Device Lot Number: M06K04-03
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 44 YR
• Patient Weight: 57