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

Model Number DM4500

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Wound Dehiscence (1154); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2023

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for a follow up.Device interrogation revealed loss of communication on an x-ray was unable to find device due to migration on the insertable cardiac monitor (icm).No changes or interventions were performed.The patient condition was unknown.

Manufacturer Narrative

Correction: b5, h6.

Event Description

It was reported that the patient presented in clinic for a follow up.Device interrogation revealed loss of communication on an x-ray was unable to find device due to it possibly falling out on the insertable cardiac monitor (icm).No changes or interventions were performed.The patient condition was unknown.

• 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: 16584561
• MDR Text Key: 311696614
• Report Number: 2017865-2023-14309
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

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: 03/15/2024
• Device Model Number: DM4500
• Device Catalogue Number: DM4500
• Device Lot Number: S000087997
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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 Age: 73 YR
• Patient Sex: Male