MAUDE Adverse Event Report: ST. JUDE/ABBOTT MEDICAL DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Model Number CDHFA500Q

Patient Problems Hypersensitivity/Allergic reaction (1907); Unspecified Infection (1930)

Event Type  Injury  

Event Description

Patient is allergic to materials used to make the device.System extraction for infection.Antibiotic treatment + leadless pacemaker implant.Reference report: mw5120646.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE/ABBOTT MEDICAL
• MDR Report Key: 17469914
• MDR Text Key: 320612811
• Report Number: MW5120645
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CDHFA500Q
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: PERMANENT DEFIBRILLATOR ELECTRODES