MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSERT-IQ¿ ICM; Recorder, event, implantable cardiac, (without arrhythmia detection)

Model Number DM5500

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

Patient Problem Wound Dehiscence (1154)

Event Date 03/29/2024

Event Type  Injury  

Event Description

It was reported that the patient presented to the clinic with wound dehiscence.It was not noted the implantable cardiac monitor (icm) eroded through the patient's skin.The physican explanted the device.The patient was in stable condition throughout the procedure.

• Brand Name: ASSERT-IQ¿ ICM
• 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: 19151777
• MDR Text Key: 340688888
• Report Number: 2017865-2024-39238
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067047809
• UDI-Public: (01)05415067047809(10)S000092843(17)250607
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230286
• 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: 04/22/2024

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 Model Number: DM5500
• Device Lot Number: S000092843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/12/2023
• 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): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White