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 Failure to Interrogate (1332); Data Problem (3196)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented to the clinic for a scheduled follow up.Upon interrogation of the implantable cardiac monitor (icm), the bluetooth low energy (ble) was unstable and eventually the ble telemetry was lost with a prompt of an error message.The physician attempted several times to interrogate the icm but was unsuccessful.The patient was in stable condition.

Manufacturer Narrative

Further information was requested but not received.

Manufacturer Narrative

The reported event of an inability to interrogate the device resulting in a programmer crash was confirmed.Based on the information provided and reviewed by abbott engineering, it was determined that the programmer crash was due to a programmer code not setting the segmentation related session attribute to 0 before requesting a bulk attribute in a new session.The device is performing per design.

• 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: 18071083
• MDR Text Key: 327368187
• Report Number: 2017865-2023-51688
• 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
• Report Date: 02/28/2024

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: S000091360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• 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 Sex: Female