MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) JOT DX¿ ICM; RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)

Model Number DM4500

Device Problems Migration or Expulsion of Device (1395); Device Sensing Problem (2917)

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

Event Date 09/10/2023

Event Type  Injury  

Event Description

It was reported that the patient's implantable cardiac monitor (icm) had sensing issues in the form of r-wave amplitude variation.There were no consequences to the patient.Further information was requested but not recieved.

Event Description

Additional information received indicated the r-wave amplitude variation noted on the implantable cardiac monitor (icm) occurred due to migration of the icm.The patient presented in clinic, where the icm was explanted and replaced successfully.The patient was stable throughout the procedure.

Manufacturer Narrative

The reported events of r-wave amp variation and migration or expulsion of device could not be confirmed.The device was received in normal working conditions with battery voltage above elective replacement indicator (eri).Dhr reviewed and found to be complete.The product passed all quality control tests prior to its distribution.The device was tested on the bench and using automated testing equipment, and no anomalies were found.

• Brand Name: JOT DX¿ 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: 17846192
• MDR Text Key: 324622686
• Report Number: 2017865-2023-47374
• 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: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM4500
• Device Lot Number: S000088213
• 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: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 81 KG