MAUDE Adverse Event Report: ST. JUDE / ABBOTT MEDICAL IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD); DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Patient Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that the patient with this right atrial (ra) lead experienced infection.A revision was performed and the icd along with the right ventricular (rv) lead and this right atrial (ra) lead were explanted.No additional adverse patient effects were reported.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Ref reports: mw5147238, mw5147239.

• Brand Name: IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (ICD)
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): ST. JUDE / ABBOTT MEDICAL
• MDR Report Key: 17985259
• MDR Text Key: 326311531
• Report Number: MW5147240
• 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: Unknown
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other