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

Model Number DM4500

Device Problems Signal Artifact/Noise (1036); Migration or Expulsion of Device (1395)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2022

Event Type  Injury  

Event Description

It was reported that after the incision was closed and the drape removed, the device was found to be lying on the patient's outer chest and not in the pocket.Noise was noted on the iegm due to the device no longer being in the patient.The device was explanted and replaced.The patient was stable.

Manufacturer Narrative

Sensing problem and device migration issue were not confirmed.The device was received in normal working conditions with battery voltage above eri.Analysis performed, including sensing test at field and high sensitivity settings indicated normal device functionality.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

Manufacturer Narrative

Correction g3: the date for the previous report follow-up 1 should have been dec 20, 2022.

• Brand Name: JOT DX¿ ICM
• 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: 15847306
• MDR Text Key: 304170569
• Report Number: 2017865-2022-46301
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067040046
• UDI-Public: 05415067040046
• 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,Followup
• Report Date: 01/10/2023

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/08/2023
• Device Model Number: DM4500
• Device Catalogue Number: DM4500
• Device Lot Number: P000148995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/22/2022
• Supplement Dates Manufacturer Received: 12/15/2022; 01/09/2023
• Supplement Dates FDA Received: 01/05/2023; 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2022
• 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): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female