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

Model Number DM5500

Device Problems Premature Discharge of Battery (1057); Failure to Interrogate (1332)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported the patient presented for implant procedure.During surgery, it was discovered the insertable cardiac monitor (icm) exhibited premature battery depletion and could not be interrogated.The physician elected to complete the procedure with a different icm.The patient was in stable condition.

Manufacturer Narrative

Further information was requested but not received.

Manufacturer Narrative

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.The reported event of failure to interrogate and premature discharge of battery were not confirmed.The device was above elective replacement indicator (eri) upon receipt.Device arrived able to interrogate and no warning message was noted.Analysis of device indicated that device was within normal range of operation.Further analysis performed showed normal device characteristics.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ASSERT-IQ¿ 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: 18352444
• MDR Text Key: 330833615
• Report Number: 2017865-2023-94949
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067047809
• UDI-Public: 05415067047809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230286
• 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: 01/29/2024

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: DM5500
• Device Lot Number: S000091701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 12/21/2023; 01/23/2024
• Supplement Dates FDA Received: 01/08/2024; 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2023
• 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
• Patient Age: 66 YR
• Patient Sex: Male