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

Model Number DM4500

Device Problem Failure to Interrogate (1332)

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

Event Type  malfunction  

Event Description

It was reported that the implantable cardiac monitor (icm) had failed to be interrogated prior to procedure.No intervention was reported.There was no patient involvement.

Manufacturer Narrative

Customer complaint of failure to interrogate was confirmed.The device was received from the field with battery voltage having reached end of life.Device could not establish telemetry and device image could not be saved.Longevity assessment was performed, and device was found to have premature discharge of battery.Device was cut open and high drain current on the hybrid was noted.An anomalous integrated circuit (ic) was found to be the cause of the high current drain and failure to interrogate.A device history record (dhr) review was performed, and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.

• 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: 18290581
• MDR Text Key: 330041211
• Report Number: 2017865-2023-94261
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM4500
• Device Lot Number: S000089276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/19/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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