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

Model Number DM5300

Device Problem Failure to Interrogate (1332)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that the insertable cardiac monitor (icm) was unable to be interrogated.

Manufacturer Narrative

Correction: the correct event description should have been "it was reported that the patient was presented for a follow-up in the clinic.It was found that the insertable cardiac monitor (icm) was failing to be interrogated via bluetooth (ble) telemetry.No intervention was performed.The programmer was moved closer to the patient and ble telemetry was able to successfully connect to the patient.There were no patient consequences." rather than "it was reported that the insertable cardiac monitor (icm) was unable to be interrogated.".

Event Description

It was reported that the patient was presented for a follow-up in the clinic.It was found that the insertable cardiac monitor (icm) was failing to be interrogated via bluetooth (ble) telemetry.No intervention was performed.The programmer was moved closer to the patient and ble telemetry was able to successfully connect to the patient.There were no patient consequences.

• 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: 18823887
• MDR Text Key: 337070642
• Report Number: 2017865-2024-33958
• Device Sequence Number: 1
• Product Code: MXC
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2024

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: DM5300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 03/08/2024; 03/15/2024
• Supplement Dates FDA Received: 03/11/2024; 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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