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

Model Number DM4500

Device Problem Failure to Interrogate (1332)

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

Event Date 12/12/2022

Event Type  Injury  

Event Description

It was reported the patient presented in clinic for follow-up.During the device check, it was discovered the insertable cardiac monitor (icm) could not be interrogated.No changes or interventions were reported.There were no patient consequences.

Event Description

New information noted the insertable cardiac monitor (icm) was explanted.The patient was in stable condition before, during, and after.

Manufacturer Narrative

The reported event of failure to interrogate was confirmed.The insertable cardiac monitor (icm) was received for analysis at end of service (eos).A longevity calculation was performed and found the battery depletion was premature.Battery voltage recovery after detachment from device excluded a battery issue for the cause of premature depletion.Current was monitored for an extensive period and no high current drain was noted on hybrid.The cause of premature battery depletion could not be determined.

• 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: 16080942
• MDR Text Key: 307261376
• Report Number: 2017865-2022-51100
• Device Sequence Number: 1
• Product Code: MXC
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: DM4500
• Device Catalogue Number: DM4500
• Device Lot Number: P000149188
• 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: 02/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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: 71 YR
• Patient Sex: Male