MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR

Model Number DM3500

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

Patient Problem Pocket Erosion (2013)

Event Date 11/22/2022

Event Type  Injury  

Event Description

It was reported that a patient presented to the emergency room with erosion of their insertable cardiac monitor (icm).The physician elected to explant the icm.The patient condition was stable after the procedure.

• Brand Name: CONFIRM
• Type of Device: IMPLANTABLE CARDIAC MONITOR
• 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: 15951700
• MDR Text Key: 305184945
• Report Number: 2017865-2022-48290
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2023
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: P000146005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male