MAUDE Adverse Event Report: ST. JUDE AMPLATZER; SEPTAL OCCLUDER

Lot Number M08A07-29

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/11/2015

Event Type  Injury  

Event Description

Septal occluder for asd was not functioning and had to be surgically removed.

• Brand Name: AMPLATZER
• Type of Device: SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE; st. paul MN 55117
• MDR Report Key: 5161582
• MDR Text Key: 28808637
• Report Number: MW5057158
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: M08A07-29
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 65