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

Model Number 1458QL-75

Patient Problems Wound Dehiscence (1154); Purulent Discharge (1812); Failure of Implant (1924)

Event Type  Injury  

Event Description

Crt-p (cardiac resynchronization therapy with a pacemaker) system removed due to infection and wound dehiscence, possibly associated with an ingrown hair at the implant site where purulent discharge was noted.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 MEDICAL/ ABBOTT MEDICAL
• MDR Report Key: 18931785
• MDR Text Key: 338156263
• Report Number: MW5152971
• 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: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1458QL-75
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1