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

Model Number DM3500

Device Problem Failure to Interrogate (1332)

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

Event Date 10/16/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the clinic for a scheduled follow up.It was noted that the implantable cardiac monitor (icm) had failed to be interrogated.The device was explanted.The patient was in stable condition.

Manufacturer Narrative

Reported event of failure to interrogate was confirmed.The insertable cardiac monitor (icm) was returned for analysis.The device was unable to establish telemetry upon receipt.Analysis after device was cut open revealed device battery voltage was at end of service (eos).A longevity calculation was performed and found the battery depletion was premature.Current was monitored for an extensive period and no high current drain was noted on hybrid.Further analysis performed on the battery by outside lab found no anomaly.The cause of premature battery depletion could not be confirmed.

• Brand Name: CONFIRM
• 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: 18052258
• MDR Text Key: 327126034
• Report Number: 2017865-2023-51215
• Device Sequence Number: 1
• Product Code: MXC
• UDI-Device Identifier: 05415067027320
• UDI-Public: 05415067027320
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DM3500
• Device Lot Number: P000173746
• 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: Not provided
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male