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

Model Number DM3500

Device Problem Signal Artifact/Noise (1036)

Patient Problem Pocket Erosion (2013)

Event Type  Injury  

Event Description

It was reported the patient presented remotely via merlin.Net.Review of the transmission revealed the insertable cardiac monitor (icm) was transmitting noise electrograms (egm).The patient was brought into clinic where it was discovered the icm had eroded completely out of the patient.No changes or interventions were reported.The patient was in stable condition.

Manufacturer Narrative

The reported event of noise was not confirmed.As received, the device was above elective replacement indicator (eri) level.Device image analysis, sensitivity test, longevity assessment was normal and no anomalies were found.

• 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: 15857362
• MDR Text Key: 304275842
• Report Number: 2017865-2022-46549
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2023
• Device Model Number: DM3500
• Device Catalogue Number: DM3500
• Device Lot Number: P000146656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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): Other
• Patient Sex: Male