MAUDE Adverse Event Report: ABBOTT 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 02/12/2024

Event Type  Injury  

Event Description

During an in clinic follow up, the device was unable to be interrogated.A device explant is anticipated but has not yet been performed.The patient was stable and will continue being monitored.

Event Description

Additional information was received indicating the device was explanted to resolve the event.The patient was stable.

• Brand Name: CONFIRM
• Type of Device: RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITHOUT ARRHYTHMIA DETECTION)
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18779546
• MDR Text Key: 336242307
• Report Number: 2017865-2024-33473
• Device Sequence Number: 1
• Product Code: MXC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K163407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

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 Expiration Date: 04/03/2024
• Device Model Number: DM3500
• Device Lot Number: P000155254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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