MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM¿ RX INCISION TOOL; Recorder, event, implantable cardiac, (without arrhythmia detection)

Model Number DM3520

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 12/21/2023

Event Type  Injury  

Event Description

It was reported that the patient presented for an implant procedure for an implantable cardiac monitor (icm).It was noted after an incision tool was used that the patient developed a hematoma.The incision tool caused the hematoma.The icm was not implanted, the procedure was abandoned, and the pocket was closed.The patient was stable following the event.

• Brand Name: CONFIRM¿ RX INCISION TOOL
• Type of Device: Recorder, event, implantable cardiac, (without arrhythmia detection)
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18477723
• MDR Text Key: 332458891
• Report Number: 2017865-2024-00781
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DM3520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DM3500 CONFIRM.
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female